Myelodysplastic Syndromes

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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:73e17bcc1a94ebd672b913e6684b1727' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:df5f8ae469adb8470aa30e5df7c98a46' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'OBJECTIVES: Primary\n<ul>\n<li>To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.</li>\n</ul>\n Secondary\n<ul>\n<li>To evaluate the safety and tolerability of palifermin.</li>\n<li>To evaluate the long-term effects of palifermin on disease outcome and survival.</li>\n<li>To compare the incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents), and incidence and duration of total parenteral nutrition (TPN) administration in patients treated with these regimens.</li>\n<li>To compare the incidence of febrile neutropenia and invasive bacterial infections in patients treated with these regimens.</li>\n<li>To determine whether palifermin versus placebo reduces the incidence of WHO grade 3 or 4 oral mucositis among allogeneic HSCT pediatric patients receiving methotrexate as graft-versus-host disease (GVHD) prophylaxis.</li>\n<li>To determine whether palifermin versus placebo reduces acute and chronic GVHD after allogeneic HSCT.</li>\n<li>To describe health care utilization (hospitalization duration, and administration of antibiotics, TPN, nasogastric-, nasojejunal- or gastrostomy-administered enteral nutrition, and blood products) in pediatric patients treated with these regimens.</li>\n</ul>\n OUTLINE: This is a multicenter study. Patients are stratified according to age in years (1 to 2 vs 3 to 11 vs 12 to 16), type of hematopoietic stem cell transplantation (HSCT) (autologous vs allogeneic), conditioning regimen (either total-body irradiation [TBI] or melphalan vs neither TBI nor melphalan). Patients are randomized to 1 of 2 treatment arms.\n<ul>\n<li>Arm I: Patients receive palifermin IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity.</li>\n</ul>\n Patients then receive palifermin IV on days 0, 1, and 2 after autologous or allogeneic HSCT.\n<ul>\n<li>Arm II: Patients receive placebo IV once daily for 3 days prior to chemotherapy and/or radiotherapy in the absence of unacceptable toxicity. Patients then receive placebo IV on days 0, 1, and 2 after autologous or allogeneic HSCT.</li>\n</ul>\n Blood samples are collected at baseline, 32 days, and 100 days after HSCT to evaluate the immunogenicity of palifermin. Oral mucositis is assessed at baseline, daily for 8 days prior to and 32 days after HSCT, or until oral mucositis has resolved by the WHO Mucositis Scale, Oral Mucositis Assessment Scale (OMAS), modified Walsh mucositis scale, Oral Mucositis Daily Questionnaire (OMDQ), and the pain categorical rating scale. After completion of HSCT, patients are followed periodically for up to 10 years.\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:a35da0cfa0a7a86f6409af67c4b7bd98' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'DISEASE CHARACTERISTICS:\n<ul>\n<li>Patients undergoing myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT) for any indication</li>\n<li>Any type of myeloablative HSCT conditioning regimen allowed</li>\n<li>Patients undergoing allogeneic HSCT may undergo 1 of the following types of donor stem cells:\n<ul>\n<li>HLA-matched sibling or parent</li>\n<li>Partially matched family donor (mismatched for a single HLA locus [class I])</li>\n<li>Fully matched unrelated marrow or peripheral blood stem cell donor</li>\n<li>HLA-matched or partially mismatched (at least 4 of 6 match) cord blood (class I or II)</li>\n</ul>\n</li>\n</ul>\n PATIENT CHARACTERISTICS:\n<ul>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test</li>\n<li>Fertile patients must use effective contraception</li>\n<li>No HIV positivity</li>\n<li>No known sensitivity to any E. coli-derived products\n<ul>\n<li>Known grade 1 to 2 allergic reactions to asparaginase allowed</li>\n<li>No prior grade 3-4 allergies to asparaginase or pegaspargase</li>\n</ul>\n</li>\n</ul>\n PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>More than 30 days since prior and no concurrent treatment with any of the following therapies:\n<ul>\n<li>Oral cryotherapy</li>\n<li>Glutamine as an oral supplement</li>\n<li>Traumeel®</li>\n<li>Gelclair®</li>\n<li>Oral vancomycin paste</li>\n<li>Low-level laser therapy</li>\n<li>An investigational product or device in another clinical trial</li>\n</ul>\n</li>\n<li>No prior palifermin or other keratinocyte growth factors</li>\n<li>No other concurrent cytotoxic drugs for conditioning or graft-vs-host disease prophylaxis\n<ul>\n<li>Intrathecal methotrexate or cytarabine for CNS involvement allowed</li>\n</ul>\n</li>\n</ul>\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:bb95235845e20e6a675762a6d3f40d7e' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Safety and tolerability of palifermin [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:ec6dbdc887d16cd51563c4748d35fa7e' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Long-term disease outcome and survival [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:8eebff6f10ca6c1fd499b9e8948d715b' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Duration of WHO grade 3 or 4 oral mucositis [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:0ba2af343f300b31fc7e925de958cb39' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence, total dose, and duration of parenteral opioid analgesic use (morphine equivalents) [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:efda079bce71216266982e184ec19e9c' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence and duration of total parenteral nutrition administration [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:02fac6ce9cae062f7b8ef9c212258471' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of febrile neutropenia and invasive bacterial infections [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:9e8fe591e820bb46408a222bc02fcaff' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of WHO grade 3 or 4 oral mucositis among allogeneic HSCT patients receiving methotrexate as GVHD prophylaxis [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:a24c53e1e9c2beb430185cc3a2a2a849' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of acute and chronic GVHD after allogeneic HSCT [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:4d84bcb8e25523003f9e0c8a53ba6cfa' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:83093853389028cd1080b0720e1d5b9d' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The "Simply Rotate" Study\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:e682a05167afedd5b7847872f75934f5' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'OBJECTIVES: Primary\n<ul>\n<li>To compare the effectiveness of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone) in controlling pain (i.e., analgesia) in patients with cancer.</li>\n</ul>\n Secondary\n<ul>\n<li>To compare the tolerability of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone).</li>\n<li>To identify a subset of patients most likely to benefit from an opioid rotation to oral methadone, in terms of significant improvement in pain control or opioid tolerability.</li>\n</ul>\n OUTLINE: This is a multicenter study. Patients are stratified according to their baseline opioid (morphine vs oxycodone). Patients are randomized to 1 of 2 treatment arms.\n<ul>\n<li>Arm I: Patients are switched from their current opioid medication (oxycodone or morphine) to methadone. Patients receive oral methadone 2-3 times daily for 4 weeks.</li>\n<li>Arm II: Patients currently receiving oxycodone are switched to sustained-release (SR) morphine. Patients currently receiving morphine are switched to SR oxycodone. Patients receive either oral SR morphine or oxycodone 2-3 times daily for 4 weeks.</li>\n</ul>\n Patients are assessed for pain control and complete a symptom questionnaire on days 1, 8, 15, 22, and 28.\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:76802cc08dc38182f705aec18b74013c' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'DISEASE CHARACTERISTICS:\n<ul>\n<li>Receiving ongoing care in the outpatient medical oncology setting</li>\n<li>Self-reported pain (of any cause) for which long-acting strong opioids (morphine or oxycodone) have been prescribed or administered\n<ul>\n<li>Oral morphine-equivalent daily dose (MEDD) of existing opioid regimen (long-acting or immediate-release) 40-300 mg/day</li>\n</ul>\n</li>\n<li>Worst pain score on a scale of 0 (no pain) to 10 (worst pain) of ≥ 5 for ≥ 1 week duration based on verbal self-report AND/OR ≥ 1 persistently bothersome symptom attributed to an opioid side effect (e.g., fatigue, confusion, depressed level of consciousness, memory loss, personality change, anorexia, constipation, dehydration, nausea, vomiting, weight loss, pruritus, urticaria, impotence, reduced libido, and urinary retention or hesitancy)</li>\n</ul>\n PATIENT CHARACTERISTICS:\n<ul>\n<li>None of the following conditions that could predispose the patient to prolonged QT interval-associated tachycardia:\n<ul>\n<li>Serum potassium < 3.0 mg/dL</li>\n<li>Cocaine abuse within the past 3 months</li>\n<li>Family history of sudden death</li>\n<li>Advanced heart failure (ejection fraction < 40% and/or NYHA class III or IV heart disease)</li>\n</ul>\n</li>\n<li>No known or suspected cognitive impairment that could interfere with adherence to the medication plan or self-report of symptoms and side effects</li>\n<li>Not pregnant or nursing</li>\n<li>Fertile patients must use effective contraception</li>\n</ul>\n PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>More than 4 weeks since prior radiotherapy or surgery for local control of cancer or pain palliation</li>\n<li>More than 60 days since prior use of the same long-acting opioid (i.e., the new long-acting opioid) that patient is switching to on the study</li>\n<li>More than 12 weeks since prior methadone therapy</li>\n<li>More than 3 days since prior and no concurrent transdermal fentanyl, oxymorphone, or buprenorphine</li>\n<li>Concurrent systemic anticancer therapy or bisphosphonates allowed provided therapy was initiated ≥ 4 weeks ago</li>\n<li>Concurrent tricyclic antidepressants, NSAIDs, anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated ≥ 2 weeks ago\n<ul>\n<li>Dose expected to remain stable until after the first week of opioid rotation on study</li>\n</ul>\n</li>\n<li>No concurrent methadone maintenance therapy for opioid addiction</li>\n<li>No concurrent intrathecal infusion of analgesics</li>\n<li>No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)</li>\n</ul>\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:b46412cca3c03de4baffb656fd8990bb' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '30% reduction in patients\' total summary score for the individual composite drug toxicity score (CDTS) items [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:16e9ff6530662c4e767ab2cbf540d2e9' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Identification of a subset of patients most likely to benefit from an opioid rotation to oral methadone, in terms of significant improvement in pain control or opioid tolerability [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:a745fbf8b3911431b7c93870d4965fdf' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'RATIONALE: A donor peripheral stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient\'s bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the donated stem cells begin working, the patient\'s immune system may see the remaining cancer cells as not belonging in the patient\'s body and destroy them. Giving an infusion of donor T cells may helps stop the patient\'s immune system from rejecting the donor\'s stem cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of donor T cells in treating patients with high-risk hematologic cancer who are undergoing donor peripheral blood stem cell transplant.\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:352d70193ede05ded78f86e5a49c20d4' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'MT2004-03: A Clinical Trial of Adult CD4+ CD25+ Regulatory T Cells in BMT Recipients Was "A Dose Escalation Study of CD4+ CD25+ Cells in Adult Patients Undergoing HLA-Identical Sibling Donor Peripheral Blood Progenitor Cell (PBPC) Transplantation&quo\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:e5186cd5855132b57983e764d3b6af1b' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'OBJECTIVES: Primary\n<ul>\n<li>To determine whether CD4- and CD25-positive regulatory T cells can be safely administered to patients with high-risk hematologic malignancies undergoing HLA-identical sibling donor peripheral blood progenitor cell (PBPC) transplantation.</li>\n</ul>\n Secondary\n<ul>\n<li>To determine the incidence of grade II-IV acute graft-versus-host-disease (GVHD), chronic GVHD, relapse, and survival after administration of CD4- and CD25-positive regulatory T cells in these patients.</li>\n</ul>\n OUTLINE: This is a dose-escalation study of CD4- and CD25-positive donor regulatory T cells followed by a phase II study. All patients receive myeloablative preparative therapy and GVHD prophylaxis as per University of Minnesota protocol UMN-MT2001-02 or UMN-MT2001-10.\n<ul>\n<li>First allogeneic peripheral blood progenitor cell (PBPC) infusion: Patients receive unmobilized, culture-expanded, CD4- and CD25-positive donor regulatory T cells IV over 15-60 minutes at the assigned dose on day -2.</li>\n<li>Second allogeneic PBPC infusion: Patients undergo matched-sibling donor PBPC transplantation IV on day 0.</li>\n</ul>\n Patients undergo blood sample collection prior to commencement of preparative therapy and then at day 100, 6 months, and 1 year after PBPC transplantation. Samples are analyzed for immune reconstitution by immunophenotyping and functional analyses. After completion of study therapy, patients are followed for up to 1 year.\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:88cc5b5198290b5cc0e09b556cb0785e' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'DISEASE CHARACTERISTICS:\n<ul>\n<li>Diagnosis of a high-risk hematologic malignancy, including any of the following:\n<ul>\n<li>Acute lymphoblastic leukemia (ALL) beyond second complete remission (CR2)</li>\n<li>Acute myeloid leukemia beyond CR2</li>\n<li>Chronic myelogenous leukemia in accelerated phase or post-blast crisis</li>\n<li>Myelodysplastic syndromes with 5-20% blasts in bone marrow</li>\n<li>Non-Hodgkin lymphoma beyond third partial remission</li>\n<li>Multiple myeloma meeting the following criterion:\n<ul>\n<li>Not a candidate for autologous stem cell transplantation</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>Must have an HLA-identical sibling donor available, meeting the following criteria:\n<ul>\n<li>12 to 75 years of age</li>\n<li>Matched to recipient for HLA-A and -B antigens using serological techniques and for DRB1 allele level using SSOP typing UMN-MT2001-02</li>\n</ul>\n</li>\n<li>Concurrently enrolled on 1 of the following protocols:\n<ul>\n<li>UMN-MT2001-02</li>\n<li>UMN-MT2001-10</li>\n</ul>\n</li>\n</ul>\n PATIENT CHARACTERISTICS:\n<ul>\n<li>Not specified</li>\n</ul>\n PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n</ul>\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:cf0204f2091e71d9a29007de741d118d' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:955254cde948984eb9e60ebac1471e8a' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Disease-free survival [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:955254cde948984eb9e60ebac1471e8a' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1e8c637579fde6f0fcb8a2651fdb18a9' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Maximum tolerated dose (Phase I) [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:1e8c637579fde6f0fcb8a2651fdb18a9' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:304374ea3ca2a087b59d8e9d97059a92' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of grade 3-5 infusional toxicity at 48 hours after a CD4- and CD25-positive regulatory T-cell infusion (phase II) [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:304374ea3ca2a087b59d8e9d97059a92' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c23c82efd2f0577ba704d51488708c2e' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Cumulative incidence of grade II-IV acute graft-versus-host-disease (GVHD) at day 100 [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:c23c82efd2f0577ba704d51488708c2e' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4e3050674aeef45c053bbe3dc185e71a' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of chronic GVHD at 6 months [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:4e3050674aeef45c053bbe3dc185e71a' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3742cbea75676c7d2a67a4ff75040626' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Relapse at 6 months [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:3742cbea75676c7d2a67a4ff75040626' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:eec69a9d1c23f750a0cbcc0bd1a4d41f' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Survival at 100 days and 1 year [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:eec69a9d1c23f750a0cbcc0bd1a4d41f' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e00d60aede74a721deb8c3df27a225b7' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells and helps stop the patient\'s immune system from rejecting the donor\'s stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient\'s blood, are infused into the patient they may help the patient\'s bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body\'s normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well umbilical cord blood transplant from an unrelated donor works in treating patients with hematologic cancer.\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:e00d60aede74a721deb8c3df27a225b7' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c01c6e81a950af7e06fbfb739324789c' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-Intensity Preparative Regimen\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:c01c6e81a950af7e06fbfb739324789c' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ae05d7e8ce3c634a8c0c7443d5d2ed6e' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'OBJECTIVES: Primary\n<ul>\n<li>To estimate probability of 1-year survival of patients with hematological malignancies undergoing a reduced-intensity preparative regimen during unrelated donor umbilical cord blood transplantation.</li>\n<li>To demonstrate equivalent or improved engraftment rates with a nonanti-thymocyte-based conditioning regimen in patients who have not received recent chemotherapy (stratum 2).</li>\n</ul>\n Second\n<ul>\n<li>To determine the 6-month nonrelapse mortality in patients treated with this regimen.</li>\n<li>To determine the overall incidence of graft failure/rejection in patients treated with this regimen.</li>\n<li>To determine the kinetics of chimeric reconstitution in patients treated with this regimen.</li>\n<li>To determine the incidence of neutrophil engraftment by day 42 in patients treated with this regimen.</li>\n<li>To determine the incidence of platelet engraftment by 6 months in patients treated with this regimen.</li>\n<li>To determine the incidence of grade II-IV and III-IV acute graft-versus-host-disease (GVHD) for each stratum in patients treated with this regimen.</li>\n<li>Incidence of one-year chronic GVHD for each stratum in patients treated with this regimen.</li>\n<li>Incidence of clinically significant infections at 6 months, 1 year, and 2 years for each stratum in patients treated with this regimen.</li>\n<li>To determine the probability of 1- and 2-year survival of patients treated with this regimen.</li>\n<li>To determine the incidence of 1- and 2-year relapse or disease progression in patients treated with this regimen.</li>\n</ul>\n OUTLINE: This is a multicenter study. Patients are stratified according to risk of graft rejection (low vs high).\n<ul>\n<li>Reduced-intensity preparative regimen with graft-vs-host disease prophylaxis: Patients receive fludarabine phosphate IV on day -6 through day -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients undergo total-body irradiation on day -1.</li>\n<li>Donor umbilical cord blood infusion: Patients undergo donor umbilical cord blood infusion on day 0.</li>\n<li>Graft-vs-host disease prophylaxis: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to +180 and mycophenolate mofetil IV or orally every 8 hours on days -3 to +96. Patients are followed periodically for up to 2 years after transplantation.</li>\n</ul>\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:ae05d7e8ce3c634a8c0c7443d5d2ed6e' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:88be77144a1a939105c8055212142f73' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'DISEASE CHARACTERISTICS:\n<ul>\n<li>Diagnosis of any of the following diseases (other diagnoses may be considered)\n<ul>\n<li>Acute myeloid leukemia with < 5% morphologic marrow blasts in an evaluable marrow (> 25% of normal cellularity for age)</li>\n<li>Acute lymphoblastic leukemia with < 5% morphologic marrow blasts in an evaluable marrow (> 25% of normal cellularity for age)</li>\n<li>Chronic myelogenous leukemia (CML) with < 5% blasts in an evaluable marrow (> 25% of normal cellularity for age) by morphology\n<ul>\n<li>All types allowed except refractory blast crisis</li>\n<li>Patients with chronic phase CML must be refractory or intolerant to imatinib mesylate or other tyrosine kinase inhibitors</li>\n</ul>\n</li>\n<li>Myelodysplastic syndromes (MDS) with morphologic blasts less than 5% in an evaluable marrow (> 25% of normal cellularity for age)\n<ul>\n<li>If blasts are 5% or more, patient must undergo induction therapy pretransplant to reduce blast count to ≤ 5%</li>\n<li>Any subtype allowed</li>\n</ul>\n</li>\n<li>Large-cell lymphoma or aggressive T-cell lymphoma, meeting 1 of the following criteria:\n<ul>\n<li>Chemotherapy-sensitive disease (defined as ≥ 50% reduction in the size of the tumor with the chemotherapy regimen immediately preceding transplant) that has failed autologous transplantation</li>\n<li>Ineligible for an autologous transplant</li>\n</ul>\n</li>\n<li>Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), meeting 1 of the following criteria:\n<ul>\n<li>Refractory to fludarabine or did not achieve a complete or partial response after therapy with a regimen containing fludarabine or another nucleoside analog (e.g., 2-CDA or pentostatin)</li>\n<li>Disease relapse within 12 months after completing therapy with a regimen containing fludarabine or another nucleoside analog</li>\n</ul>\n</li>\n<li>Hodgkin lymphoma\n<ul>\n<li>Refractory to prior front-line therapy</li>\n</ul>\n</li>\n<li>Follicular lymphoma, marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma, mantle cell lymphoma, or indolent T-cell lymphomas\n<ul>\n<li>Disease progressed; most recent remission duration < 6 months</li>\n<li>Patients with bulky disease should be considered for debulking chemotherapy before transplant</li>\n<li>Patients with refractory disease are eligible, unless they have bulky disease and an estimated tumor doubling time of less than one month</li>\n</ul>\n</li>\n<li>Multiple myeloma\n<ul>\n<li>Must have received prior chemotherapy; prior consolidation of chemotherapy by autografting prior to nonmyeloablative hematopoietic stem cell transplantation allowed</li>\n</ul>\n</li>\n<li>Myeloproliferative syndromes</li>\n</ul>\n</li>\n<li>Meets 1 of the following criteria for risk of graft rejection\n<ul>\n<li>At lower risk for graft failure, meeting 1 of the following criteria (stratum 1):\n<ul>\n<li>Received a previous autologous transplant within the past 12 months</li>\n<li>Received ≥ 2 courses of multiagent chemotherapy with ≥ 1 course of therapy within the past 3 months\n<ul>\n<li>Chemotherapy is defined as cytotoxic therapy with the intention of inducing complete response; targeted therapeutics including, but not limited to, histone deacetylase inhibitors, hypomethylating agents, immunomodulatory agents, and tyrosine kinase inhibitors are not considered chemotherapies</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>At higher risk for graft failure (stratum 2)\n<ul>\n<li>Have not undergone autologous transplantation within the past 12 months, and meets 1 of the following criteria:\n<ul>\n<li>Received < 2 courses of multiagent chemotherapy</li>\n<li>Received no multiagent chemotherapy within the past 3 months</li>\n</ul>\n</li>\n<li>Patients who have experienced graft failure following prior allogeneic transplantation are allowed</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>Patient and the cord blood unit(s) must be matched for at least 4 of 6 loci\n<ul>\n<li>No 5-6/6 HLA-A, -B, -DRB1 matched-sibling donor or 10/10 matched-unrelated donor available</li>\n</ul>\n</li>\n<li>No active central nervous system malignancy</li>\n</ul>\n PATIENT CHARACTERISTICS:\n<ul>\n<li>Karnofsky performance status (PS) 60-100% (for adults) or Lansky PS 50-100% (for children)</li>\n<li>No decompensated congestive heart failure or uncontrolled arrhythmia</li>\n<li>LVEF ≥ 35%</li>\n<li>DLCO > 30% predicted</li>\n<li>No requirement for supplemental oxygen</li>\n<li>Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, histology, and the degree of portal hypertension; patients with the following hepatic conditions will be ineligible:\n<ul>\n<li>Fulminant liver failure</li>\n<li>Cirrhosis with evidence of portal hypertension or bridging fibrosis</li>\n<li>Alcoholic hepatitis</li>\n<li>Esophageal varices</li>\n<li>History of bleeding esophageal varices</li>\n<li>Hepatic encephalopathy</li>\n<li>Correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time</li>\n<li>Ascites related to portal hypertension</li>\n<li>Bacterial or fungal abscess</li>\n<li>Biliary obstruction</li>\n<li>Chronic viral hepatitis with total serum bilirubin > 3 mg/dL</li>\n<li>Symptomatic biliary disease</li>\n</ul>\n</li>\n<li>Creatinine < 2.0 mg/dL (adults)\n<ul>\n<li>Adults with creatinine > 1.2 mg/dL or history of renal dysfunction must have estimated creatinine clearance > 40 mL/min</li>\n</ul>\n</li>\n<li>Creatinine clearance > 40 mL/min (pediatrics)</li>\n<li>Not pregnant or nursing</li>\n<li>Fertile patients must use effective contraception</li>\n<li>No evidence of HIV infection or known HIV-positive serology</li>\n<li>No uncontrolled viral or bacterial infection\n<ul>\n<li>Recent mold infection (e.g., Aspergillus) allowed provided the patient has received a minimum of 30 days of appropriate treatment; infection must be controlled</li>\n<li>No active or recent (within the previous 6 months) invasive fungal infection without Infectious Disease consult and approval</li>\n</ul>\n</li>\n</ul>\n PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>At least 3 months since prior myeloablative transplantation</li>\n</ul>\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:88be77144a1a939105c8055212142f73' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0e79568ecdbbf006d075c1c708fed460' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Progression-free survival [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:0e79568ecdbbf006d075c1c708fed460' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:396cbeb3ce660f8b5c8bea6303bc0b67' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Relapse [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:396cbeb3ce660f8b5c8bea6303bc0b67' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a07c05731de9857f46ad56bd19af5ccf' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Survival at 1 year [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:a07c05731de9857f46ad56bd19af5ccf' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a2a232380332aea5e4fc33a57ab6b75c' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Acute and chronic GVHD [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:a2a232380332aea5e4fc33a57ab6b75c' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dae817d15fd0a31be0a830f07ce73f9c' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Engraftment rates [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:dae817d15fd0a31be0a830f07ce73f9c' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0ef948118a739a7e0a702e8bcc38665d' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Overall survival (i.e., beyond 1 year) [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:0ef948118a739a7e0a702e8bcc38665d' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:23aa2a1679892cefc0edaebf80a67752' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Nonrelapse mortality at 6 months, 1 year, and overall [ Designated as safety issue: No ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:23aa2a1679892cefc0edaebf80a67752' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:20f30ddcd038268ca6b0197aafbad2d6' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of graft failure/rejection [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:20f30ddcd038268ca6b0197aafbad2d6' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d62a5110a9f53861e9a571b1f072f620' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Neutrophil and platelet engraftment [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:d62a5110a9f53861e9a571b1f072f620' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:901b0c4238873f5dbf9931efb1e1b857' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Clinically significant infections [ Designated as safety issue: Yes ]\n', created = 1283574274, expire = 1283660674, headers = '', serialized = 0 WHERE cid = '1:901b0c4238873f5dbf9931efb1e1b857' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:729607d5867441cef15860f291f0b9a6' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'The hypothesis of this study is that lenalidomide can be an effective drug in preventing relapse of MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q after allogeneic HSCT. Due to its immunomodulatory action it might also be able to enhance a T - or NK cell mediated graft versus leukemia (GVL) effects. Nevertheless, one has to keep in mind a possible, yet unknown influence on modulation of clinical GVHD.\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:729607d5867441cef15860f291f0b9a6' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dc4a3bfa3c0c641f863998196f3c1f6e' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient\'s immune system from rejecting the donor\'s stem cells. When the stem cells from a related or unrelated donor, that do not exactly match the patient\'s blood, are infused into the patient they may help the patient\'s bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body\'s normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well umbilical cord blood transplant given together with cyclophosphamide, fludarabine, and total-body irradiation works in treating patients with hematologic disease.\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:dc4a3bfa3c0c641f863998196f3c1f6e' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8e3bec6ea723cdc059b530d2035cb8ee' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:8e3bec6ea723cdc059b530d2035cb8ee' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4f85805d5a35396ee5e0f643a8d3b4e4' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'OBJECTIVES: Primary\n<ul>\n<li>The 1-year survival of patients with hematological malignancies undergoing umbilical cord blood transplantation after a myeloablative preparative regimen comprising of cyclophosphamide, fludarabine, and fractionated total-body irradiation.</li>\n</ul>\n Secondary\n<ul>\n<li>The incidence of transplant-related mortality at 6 months.</li>\n<li>The chimerism at multiple time points.</li>\n<li>The incidence of neutrophil engraftment at day 42.</li>\n<li>The incidence of platelet engraftment at 6 months.</li>\n<li>The incidence of acute graft-versus-host disease (GVHD) grade II-IV and grade III-IV at day 100.</li>\n<li>The incidence of chronic GVHD at day 100, 1 year, and 2 years.</li>\n<li>The incidence of clinically significant infections at 6 months, 1 year, and 2 years.</li>\n<li>The incidence of disease-free survival at 1 and 2 years.</li>\n<li>The incidence of relapse at 1 and 2 years.</li>\n</ul>\n OUTLINE:\n<ul>\n<li>Conditioning regimen: Patients receive fludarabine IV over 1 hour on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo total-body irradiation twice daily on days -4 to -1.</li>\n<li>Umbilical cord blood transplantation (UCBT): Patients undergo UCBT on day 0. Patients receive filgrastim (G-CSF) IV (pediatric) or subcutaneously (adult) beginning on day 1 and continuing until blood counts recover.</li>\n<li>Graft-versus-host disease prophylaxis (GVHD): Patients receive cyclosporine orally or IV over 1 hour twice daily (adult) or three times daily (pediatric) beginning on day -3 and continuing until day 100 and then taper. Patients also receive mycophenolate mofetil (MMF) IV three times daily on days -3 to 5 and then orally on days 6-30. MMF will be discontinued on day 30 or 7 if there is no acute GVHD.</li>\n</ul>\n After completion of study treatment, patients are followed at 6 months, 1 year, and 2 years.\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:4f85805d5a35396ee5e0f643a8d3b4e4' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:79283ad5727bf84551b4f8e69168df2c' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'DISEASE CHARACTERISTICS:\n<ul>\n<li>Diagnosis of hematological malignancy, meeting any of the following criteria:\n<ul>\n<li>Acute Myeloid Leukemia (AML)\n<ul>\n<li>High-risk complete remission (CR) 1 as evidenced by preceding myelodysplastic syndrome (MDS), high risk cytogenetics (e.g., monosomy 5 or 7) OR high-risk as defined by referring institution treatment protocol, ≥ 2 courses to obtain CR, erythroblastic or megakaryocytic leukemia, and ≥ CR2</li>\n<li>All patients must be in CR as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of\n<ul>\n<li>15%</li>\n</ul>\n</li>\n<li>Patients in which adequate marrow/biopsy specimens can not be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible and must be discussed with the Principal Investigator</li>\n<li>Patients < 21 years of age are eligible if M2 marrow is present with ≤ 25% blasts in marrow after having failed at least 1 course of chemotherapy</li>\n</ul>\n</li>\n<li>Acute lymphoblastic leukemia\n<ul>\n<li>High-risk CR1 [e.g., t(9;22), t(1;19), t(4;11) or other MLL rearrangements, or haplodiploidy]</li>\n<li>Required > 1 course to obtain CR</li>\n<li>In ≥ CR2</li>\n<li>All patients must be in CR as defined by hematologic recovery and < 5% blasts by morphology within the bone marrow and a cellularity of\n<ul>\n<li>15%</li>\n</ul>\n</li>\n<li>Patients in which adequate marrow/biopsy specimens can not be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible and must be discussed with the Principal Investigator</li>\n</ul>\n</li>\n<li>Chronic myelogenous leukemia, excluding refractory blast crisis\n<ul>\n<li>Patients must have failed or be intolerant to imatinib mesylate to be eligible in first chronic phase (CP1)</li>\n</ul>\n</li>\n<li>Advanced myelofibrosis</li>\n<li>MDS in intermediate-2 by International Prognostic Scoring System, high-risk (i.e., refractory anemia with excess blasts [RAEB] or RAEB in transformation), refractory anemia with severe pancytopenia, or high-risk cytogenetics (blasts must be < 10% by a representative bone marrow aspirate morphology)</li>\n<li>Lymphoblastic lymphoma, Burkitt lymphoma, or other high-grade non-Hodgkin lymphoma (NHL) after initial therapy if stage III/IV in partial remission (PR) 1 or after progression if stage I/II < 1 year (stage III/IV patients are eligible after progression in CR/PR)</li>\n<li>Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma, or follicular lymphoma that has progressed after at least two different prior therapies\n<ul>\n<li>Patients with bulky disease (nodal mass > 5 cm) should be considered for debulking chemotherapy before transplant</li>\n</ul>\n</li>\n<li>Patients with mantle cell lymphoma or prolymphocytic leukemia are eligible after initial therapy in ≥ CR1 or ≥ PR1</li>\n<li>Large cell NHL > CR2 and > PR2\n<ul>\n<li>Patients in CR2/PR2 with initial short remission (< 6 months) are eligible</li>\n</ul>\n</li>\n<li>Multiple myeloma beyond PR2\n<ul>\n<li>Patients with chromosome 13 abnormalities and first response lasting < 6 months or β-2 microglobulin > 3 mg/L may be eligible after initial therapy</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>No chemotherapy-refractory large cell or high-grade NHL (i.e., progressive disease after > 2 salvage regimens)</li>\n<li>UCB graft matched at 4-6 HLA-A, -B, -DRB1 antigens with the recipient\n<ul>\n<li>May include 0-2 antigen mismatches at the A or B or DRB1 loci</li>\n<li>If 2 UCB units are required to reach the target cell dose, each unit must be a 3-6 HLA-A, -B, -DRB1 antigen match to each other, as well as a 4-6 antigen match to the recipient</li>\n</ul>\n</li>\n</ul>\n PATIENT CHARACTERISTICS:\n<ul>\n<li>Karnofsky performance status (PS) 70-100% (adults) OR Lansky PS 50-100% (children)</li>\n<li>Creatinine < 2.0 mg/dL (adults) OR creatinine clearance > 60 mL/min (children)</li>\n<li>Not pregnant or nursing</li>\n<li>None of the following conditions or diseases:\n<ul>\n<li>Fulminant liver failure</li>\n<li>Cirrhosis with evidence of portal hypertension or bridging fibrosis</li>\n<li>Alcoholic hepatitis</li>\n<li>Esophageal varices</li>\n<li>History of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time</li>\n<li>Ascites related to portal hypertension</li>\n<li>Bacterial or fungal abscess</li>\n<li>Biliary obstruction</li>\n<li>Chronic viral hepatitis with total serum bilirubin > 3 mg/dL</li>\n<li>Symptomatic biliary disease</li>\n</ul>\n</li>\n<li>DLCO corrected > 50% normal</li>\n<li>Left ventricular ejection fraction > 45%</li>\n<li>No uncontrolled viral or bacterial infection at the time of study enrollment</li>\n<li>No active or recent (prior 6 months) invasive fungal infection without Infectious Disease consult and approval</li>\n<li>No history of HIV infection</li>\n</ul>\n PRIOR CONCURRENT THERAPY:\n<ul>\n<li>At least 6 months since prior myeloablative transplantation (patients ≤ 18 years of age)</li>\n<li>No prior myeloablative allotransplantation or autologous transplantation (patients > 18 years of age)</li>\n<li>No more than 12 months since prior extensive alkylator therapy (6 months for alkylator therapy with extensive radiation)</li>\n<li>No prior Y-90 ibritumomab or I-131 tositumomab as part of salvage therapy</li>\n</ul>\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:79283ad5727bf84551b4f8e69168df2c' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:bb181f79c12a7012c1d08c4d0ba6070a' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Acute graft-versus-host disease (GVHD) [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:bb181f79c12a7012c1d08c4d0ba6070a' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e55fd3e890e97a72bd36275787cc2c3d' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Chronic GVHD [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:e55fd3e890e97a72bd36275787cc2c3d' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:55c4ef8a4ce10f58cf797985f472769a' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Progression-free survival at 1 and 2 years [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:55c4ef8a4ce10f58cf797985f472769a' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:987bb688c8aa246079fb4c2eef5e4c05' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Transplant-related mortality at 6 months [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:987bb688c8aa246079fb4c2eef5e4c05' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ed2002e7ad4822d38a53047b75a2b412' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Chimerism at multiple time points [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:ed2002e7ad4822d38a53047b75a2b412' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:03de113be77755098579c3c6e2c35fa3' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Neutrophil engraftment at day 42 [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:03de113be77755098579c3c6e2c35fa3' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a41cc9504125ed797290984448cda022' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Platelet recovery at 6 months [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:a41cc9504125ed797290984448cda022' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c3c9dee01578e9bf8309191fe1f3529a' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Clinically significant infections at multiple time points [ Designated as safety issue: Yes ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:c3c9dee01578e9bf8309191fe1f3529a' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d72258c2b1207c256d46c8b6b2a2e167' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Relapse at 1 and 2 years [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:d72258c2b1207c256d46c8b6b2a2e167' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5075e7d372c158e19e77e61332bf30ac' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Comparison of single unit UCB transplants with historical controls [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:5075e7d372c158e19e77e61332bf30ac' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7e95cb9eac1b8088aa20fee161bc1639' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Comparison of single unit UCB transplants with double unit UCB transplants [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:7e95cb9eac1b8088aa20fee161bc1639' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a5051a61889f5d358d21ca58f3b66b24' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It may also stop the patient\'s immune system from rejecting the donor\'s stem cells. The donated stem cells may replace the patient\'s immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body\'s normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematological cancer or other disease.\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:a5051a61889f5d358d21ca58f3b66b24' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:65f45b87c478a89b211fcc850e7fba8d' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:65f45b87c478a89b211fcc850e7fba8d' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:380e6f4971b6da4c695ccea13830dbd0' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'OBJECTIVES: Primary\n<ul>\n<li>To estimate the probability of survival at 1 year in patients with advanced hematological malignancies or other diseases treated with non-myeloablative unrelated donor umbilical cord blood transplantation.</li>\n</ul>\n Secondary\n<ul>\n<li>Six Month non-relapse mortality.</li>\n<li>Chimerism at days 7, 14, 21, 28, 56, and 80, at 6 months, and at 1 and 2 years.</li>\n<li>To determine the incidence of neutrophil engraftment at day 42.</li>\n<li>To determine the incidence of platelet engraftment at 6 months.</li>\n<li>To determine the incidence of grade II-IV and III-IV acute graft-versus-host-disease (GVHD) at day 100.</li>\n<li>To determine the incidence of chronic GVHD at 1 year.</li>\n<li>To determine the incidence of clinically significant infections at 6 months and at 1 and 2 years.</li>\n<li>To determine the probability of progression-free survival at 1 and 2 years.</li>\n<li>To determine the probability of survival at 2 years.</li>\n<li>To determine the incidence of relapse or disease progression at 1 and 2 years.</li>\n</ul>\n OUTLINE: This is a multicenter study. Patients are stratified according to disease status and prior therapy (hematologic malignancy or other disease that was treated with an autologous stem cell transplant or ≥ 2 courses of multiagent chemotherapy within the past 3 months vs hematologic malignancy or other disease that was treated with an autologous stem cell transplant > 12 months ago or with ≤ 1 course of multiagent chemotherapy or immunosuppressive chemotherapy within the past 3 months vs refractory leukemia or lymphoma for which patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy).\n<ul>\n<li>Conditioning regimen: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV on day -6. Patients also undergo total body irradiation on day -1. Some patients also receive anti-thymocyte globulin IV on days -6 to -4.</li>\n<li>Umbilical cord blood transplantation (UCBT): Patients undergo UCBT on day 0.</li>\n<li>Immunosuppressive therapy (graft-versus-host disease prophylaxis): Patients receive cyclosporine IV over 1 hour or orally (as tolerated) every 8 or 12 hours beginning on day -3 and continuing for approximately 6 months. Patients also receive mycophenolate mofetil IV every 8 hours on days -3 to 5 and then orally on days 6-30. After completion of study treatment, patients are followed at 6 months and then annually thereafter.</li>\n</ul>\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:380e6f4971b6da4c695ccea13830dbd0' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6fe800b4b5eebda623c7d8c868883582' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'DISEASE CHARACTERISTICS:\n<ul>\n<li>Diagnosis of advanced hematologic malignancy or other disease not curable by conventional chemotherapy, including any of the following:\n<ul>\n<li>Acute myeloid leukemia in complete remission (CR)* (as defined by hematologic recovery, < 5% blasts in the bone marrow by morphology, and a cellularity of > 15%), meeting one of the following criteria:\n<ul>\n<li>In first complete remission (CR1) AND has high-risk disease as evidenced by any of the following:\n<ul>\n<li>Preceding myelodysplastic syndromes (MDS)</li>\n<li>High-risk cytogenetics (e.g., monosomy 5 or 7, or as defined by referring institution treatment protocol)</li>\n<li>Required > 2 courses of therapy to obtain CR</li>\n<li>Erythroblastic or megakaryocytic leukemia</li>\n</ul>\n</li>\n<li>In second CR (CR2) or beyond</li>\n</ul>\n</li>\n<li>Acute lymphoblastic leukemia in CR* (as defined by hematologic recovery, < 5% blasts in the bone marrow by morphology, and a cellularity of > 15%), meeting one of the following criteria:\n<ul>\n<li>In CR1 AND has high-risk disease as evidenced by any of the following:\n<ul>\n<li>t(9;22), t(1;19), t(4;11), or other MLL rearrangements</li>\n<li>Hyplodiploid</li>\n<li>Required > 1 course of therapy to obtain CR</li>\n</ul>\n</li>\n<li>Beyond CR2</li>\n</ul>\n</li>\n<li>Chronic myelogenous leukemia (CML)\n<ul>\n<li>All types are allowed (except refractory blast crisis CML)</li>\n<li>Patients in chronic phase CML must have failed or been intolerant to prior imatinib mesylate (Gleevec) or other tyrosine kinase inhibitors</li>\n</ul>\n</li>\n<li>MDS\n<ul>\n<li>Any subtype allowed (including refractory anemia [RA])</li>\n<li>Severe pancytopenia or complex cytogenetics</li>\n<li>Blasts must be < 5% (if blasts are ≥ 5%, pre-transplant induction therapy is required to reduce blast count to < 5%)</li>\n</ul>\n</li>\n<li>Large cell lymphoma, Hodgkin lymphoma, or multiple myeloma, meeting one of the following criteria:\n<ul>\n<li>Chemotherapy-sensitive disease that has failed prior therapy\n<ul>\n<li>Patients with large cell lymphoma or Hodgkin lymphoma must not have progressive disease during salvage therapy (stable disease allowed provided it is non-bulky)</li>\n</ul>\n</li>\n<li>Ineligible for an autologous stem cell transplant</li>\n</ul>\n</li>\n<li>Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, or follicular lymphoma that has progressed after ≥ 2 prior therapies\n<ul>\n<li>Patients with bulky disease should be considered for debulking chemotherapy prior to transplant</li>\n<li>Patients with refractory disease are eligible provided disease is non-bulky AND an estimated tumor doubling time is ≥ 1 month</li>\n</ul>\n</li>\n<li>Lymphoplasmacytic lymphoma, mantle cell lymphoma, or prolymphocytic leukemia\n<ul>\n<li>Chemotherapy-sensitive disease that was previously treated with initial therapy\n<ul>\n<li>Patients with mantle cell lymphoma must not have progressive disease during salvage therapy (stable disease allowed provided it is non-bulky)</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>Mycosis fungoides and Sezary syndrome</li>\n<li>Bone marrow failure syndromes, except for Fanconi anemia</li>\n<li>Myeloproliferative syndromes NOTE: *Patients for whom adequate marrow/biopsy specimens can not be obtained to determine remission status by morphologic assessment must have fulfilled criteria of remission (< 5% blasts by flow cytometry and recovery of peripheral blood counts with no circulating blasts)</li>\n</ul>\n</li>\n<li>Ineligible for autologous stem cell transplant due to any of the following:\n<ul>\n<li>Prior autologous stem cell transplant</li>\n<li>Inadequate autologous stem cell harvest</li>\n<li>Inability to withstand a myeloablative preparative regimen</li>\n<li>Clinically aggressive/high-risk disease</li>\n</ul>\n</li>\n<li>No evidence of progressive disease by imaging modalities or biopsy (persistent PET scan activity allowed provided there are no CT scan changes indicating progression)</li>\n<li>Acute leukemia that is refractory, persistent, or relapsed (defined as > 5% blasts in normocellular bone marrow) allowed provided patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy</li>\n<li>Patients with stable disease are eligible provided the largest residual nodal mass is approximately < 5 cm (largest residual mass must represent a 50% reduction and be approximately < 7.5 cm for patients who have responded to prior therapy)</li>\n<li>No active CNS malignancy</li>\n<li>Umbilical cord blood (UCB) donor available\n<ul>\n<li>UCB graft matched at 4/6 HLA-A, -B, and -DRB1 antigens with the recipient\n<ul>\n<li>May include 0-2 antigen mismatches at the A, B, or DRB1 loci</li>\n<li>Unit selection based on cryopreserved nucleated cell dose and HLA-A, -B, and -DRB1 using intermediate resolution A, B antigen and DRB1 allele typing</li>\n</ul>\n</li>\n<li>If 2 UCB units are required to reach the target cell dose, each unit must be a 3/6 HLA-A, -B, and -DRB1 antigen match to each other, as well as a 4/6 antigen match to the recipient</li>\n<li>No 5-6/6 HLA-A, -B, and -DRB1 matched sibling donor available</li>\n</ul>\n</li>\n</ul>\n PATIENT CHARACTERISTICS:\n<ul>\n<li>Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100%</li>\n<li>Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance > 40 mL/min (pediatrics)\n<ul>\n<li>Adult patients with a creatinine > 1.2 mg/dL or a history of renal dysfunction must have an estimated creatinine clearance of > 40 mL/min</li>\n</ul>\n</li>\n<li>Not pregnant or nursing</li>\n<li>Negative pregnancy test</li>\n<li>LVEF ≥ 35%</li>\n<li>DLCO > 30% predicted</li>\n<li>No requirement for O_2</li>\n<li>No decompensated congestive heart failure</li>\n<li>No uncontrolled arrhythmia</li>\n<li>None of the following liver diseases or conditions:\n<ul>\n<li>Fulminant liver failure</li>\n<li>Cirrhosis with evidence of portal hypertension or bridging fibrosis</li>\n<li>Alcoholic hepatitis</li>\n<li>Esophageal varices</li>\n<li>History of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time</li>\n<li>Ascites related to portal hypertension</li>\n<li>Bacterial or fungal abscess</li>\n<li>Biliary obstruction</li>\n<li>Chronic viral hepatitis with total serum bilirubin > 3 mg/dL</li>\n<li>Symptomatic biliary disease</li>\n</ul>\n</li>\n<li>Recent mold infection (e.g., Aspergillus) allowed provided patient received ≥ 30 days of appropriate treatment AND infection is controlled and cleared by Infectious Disease</li>\n<li>No evidence of HIV infection or known HIV-positive serology</li>\n<li>No uncontrolled viral or bacterial infection</li>\n</ul>\n PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n<li>At least 3 months since prior myeloablative stem cell transplantation</li>\n</ul>\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:6fe800b4b5eebda623c7d8c868883582' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6777cd025297ed91beb81e60e527b3b6' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Probability of survival at 2 years [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:6777cd025297ed91beb81e60e527b3b6' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a5a90269f9ea8d1bca2ea1136943f856' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of non-relapse mortality at 6 months [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:a5a90269f9ea8d1bca2ea1136943f856' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6c5a4fbe135086479d355ba174ba23fb' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Chimerism at days 7, 14, 21, 28, 56, and 80, at 6 months, and at 1 and 2 years [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:6c5a4fbe135086479d355ba174ba23fb' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:64f23d334170300081e62e2d0606d149' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of neutrophil engraftment at day 42 [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:64f23d334170300081e62e2d0606d149' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8da0af707c295dfd9ab28dc1335078e5' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of platelet engraftment at 6 months [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:8da0af707c295dfd9ab28dc1335078e5' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6c00b649ce50e4c24929e434b5fe2ef1' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of acute graft-versus-host-disease (GVHD) at day 100 and extensive chronic GVHD at 1 year [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:6c00b649ce50e4c24929e434b5fe2ef1' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:40394b0d9c9a3d1fa9be28125ce62293' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of clinically significant infections at 6 months and at 1 and 2 years [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:40394b0d9c9a3d1fa9be28125ce62293' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9e2eee4653b7cfdb1e2c3609a6fd2029' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Probability of progression-free survival at 1 and 2 years [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:9e2eee4653b7cfdb1e2c3609a6fd2029' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5ed11b27ca09fefbe28a71afc8e52f6c' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Incidence of relapse at 1 and 2 years [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:5ed11b27ca09fefbe28a71afc8e52f6c' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b81b29c0208266a45a9e7b15fe03553d' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'This is a phase I dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced myeloid malignancies.\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:b81b29c0208266a45a9e7b15fe03553d' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dc91e02ac3c63c9367b0121b388c5629' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'A Phase I Study of SB1518 for the Treatment of Advanced Myeloid Malignancies\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:dc91e02ac3c63c9367b0121b388c5629' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = ' \n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:80e86a76f985843c0070442e50393e8a' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Inclusion Criteria:\n<ul>\n<li>Subjects with histologically confirmed myeloid malignancy who have failed standard therapies or are not candidates for palliative therapies. This includes the following:\n<ul>\n<li>Subjects with Acute Myelogenous Leukemia (AML)</li>\n<li>Subjects with Chronic Myelogenous Leukemia (CML) in accelerated phase</li>\n<li>Subjects with Chronic Myelogenous Leukemia (CML) in blast crisis</li>\n<li>Subjects with high-risk Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)</li>\n<li>Subjects with Advanced Myelofibrosis (MF)</li>\n</ul>\n</li>\n<li>Age ≥ 18 years old</li>\n<li>Eastern Co-operative Oncology Group (ECOG) performance status 0-2</li>\n<li>All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug</li>\n<li>Able to understand and willing to sign the informed consent form</li>\n</ul>\n Exclusion Criteria:\n<ul>\n<li>Subjects with Chronic Myelogenous Leukemia (CML) in chronic phase</li>\n<li>Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study</li>\n<li>Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study</li>\n<li>Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy)</li>\n<li>Known active Hepatitis A, B or C</li>\n<li>Women who are pregnant or lactating</li>\n</ul>\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:80e86a76f985843c0070442e50393e8a' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:247797c88fc5b3b294fd154a3bbeaf6c' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Assess the safety and tolerability of SB1518, administered once daily in subjects with advanced myeloid malignancies [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:247797c88fc5b3b294fd154a3bbeaf6c' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:27d1a7879ed21447863a2916a2f7e986' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Assess the pharmacokinetic and pharmacodynamic profile of SB1518 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:27d1a7879ed21447863a2916a2f7e986' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:185129916b60e3f800b86464f1910050' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue. PURPOSE: This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:185129916b60e3f800b86464f1910050' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6e3195a0a1c531f2c83403ad8eddd2cf' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Toxicities [ Designated as safety issue: Yes ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:6e3195a0a1c531f2c83403ad8eddd2cf' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0abbed8980d36b283c3f4bde494a3e61' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Impact on physical, mental, and emotional states and vigor as measured by other subscales of the MFSI-SF and BFI [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:0abbed8980d36b283c3f4bde494a3e61' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:554f38043d3ac266ea2f71ac1dce07d6' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Fatigue as measured by the BFI and Linear Analogue Scale Fatigue [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:554f38043d3ac266ea2f71ac1dce07d6' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5ed3bd456d02aec60b46680b0cc4bc04' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Fatigue-inertia, vigor-activity, tension-anxiety, anger-hostility, and confusion-bewilderment as measured by POMS and subscales of the MFSI-SF [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:5ed3bd456d02aec60b46680b0cc4bc04' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:468edc2f3a8b61efea3d652231d56885' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Impact on stress/fatigue as measured by Perceived Stress Scale [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:468edc2f3a8b61efea3d652231d56885' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9707e747feac0d2459c10c45235736d6' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Efficacy on fatigue in minority populations [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:9707e747feac0d2459c10c45235736d6' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:eedd2ab1d6bd6b6c45c06f9f6c1d1e90' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Impact of Wisconsin Ginseng on the expression of cortisol and cytokine in fatigued cancer survivors [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:eedd2ab1d6bd6b6c45c06f9f6c1d1e90' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:79a9195d9d2f2472c37e9f02ad13c14b' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:79a9195d9d2f2472c37e9f02ad13c14b' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8f9e1735504ba32f7845621b1da696c0' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:8f9e1735504ba32f7845621b1da696c0' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5548c5e83b1d8f6e027810bc4d10ea38' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'RATIONALE: Tests that measure certain changes in blood in patients at high risk of cytomegalovirus infection may help doctors learn more about predicting cytomegalovirus infection after donor stem cell transplant. PURPOSE: This clinical trial is studying tests that measure changes in the blood in patients at high risk of cytomegalovirus infection after undergoing donor bone marrow transplant or peripheral stem cell transplant.\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:5548c5e83b1d8f6e027810bc4d10ea38' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6534b7a395b3a7e33cffe87ce702a952' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'CMV Specific Cellular Immunity in Recipients of Allogeneic Bone Marrow Transplantation: Association of CMV-Specific HLA-Peptide Tetramer Binding With Cytotoxic T-Cell Function, CMV Infection and Other Clinical Events\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:6534b7a395b3a7e33cffe87ce702a952' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b8c41f31490307111c6ab3d5876d8c72' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'OBJECTIVES:\n<ul>\n<li>To document the quantitative characteristics of a cytomegalovirus (CMV)-specific HLA-peptide tetramer-binding assay (TBA) for cytotoxic T lymphocytes (CTLs) in patients who have undergone allogeneic bone marrow transplantation (BMT) or peripheral blood stem cell transplantation (PBSCT).</li>\n<li>To confirm the optimal TBA conditions for CTL characterization in these patients.</li>\n<li>To compare the TBA results for these patients with conventional assays for CTL functions.</li>\n<li>To compare CMV-specific TBA during the first 3 months after allogeneic BMT or PBSCT and to determine whether this binding function, in either donor or recipient, is a surrogate marker for protection from risk of CMV infection in these patients.</li>\n<li>To determine whether acquisition of CMV-specific TBA protects from risk for CMV disease in patients having active CMV infection after allogeneic BMT or PBSCT.</li>\n</ul>\n OUTLINE: This is a multicenter study. Patients accrue initially to cohort 1 until a sufficient number of stem cell transplantation (SCT) recipients are enrolled. Patients then accrue to cohort 2 based on documented cytomegalovirus (CMV) infection and preemptive treatment with ganciclovir within 90 days after SCT (patients previously accrued to cohort 1 can be accrued to cohort 2 if they develop CMV infection).\n<ul>\n<li>Cohort 1: Patients undergo blood sample collection on approximately days 40, 90, 120, 150, 180, and 360 post transplantation. Samples are analyzed (to determine the development of CMV immunity) for prevalence of CMV-specific cytotoxic T-lymphocytes (CTL) by HLA-peptide tetramer-binding assay (TBA) pp65, with and without in vitro stimulation (IVS). Samples collected on days 40 and 90 are also analyzed by chromium release assay (CRA). Patients suspected of developing CMV viremia may receive ganciclovir according to standard clinical practice.</li>\n<li>Cohort 2: Patients undergo blood sample collection on approximately days 90, 120, 150, 180, and 360 after SCT. Samples are analyzed by TBApp65 staining and for prospective measurement of CMV-specific CTL functions. All patients undergo routine clinical surveillance for CMV infection on days 21 to 100 after SCT. CMV viral load measurements are obtained twice weekly by CMV-DNA PCR assays on blood cells and plasma and shell-vial blood cultures. In cohort 2, CMV viral load is also determined on days 90 (if not previously as part of cohort 1), 120, 150, 180, and 360. The CMV infection data obtained is then compared with TBA and CTL measurements using HLA-specific tetramers and IVS-induced cytotoxicity assays. Clinical events, such as graft-versus-host disease, underlying disease status, and procedure-related complications are also analyzed and correlated with TBA results.</li>\n</ul>\n Stromal cell cultures are obtained from marrow donors at the time of marrow harvest for use as target cells in CTL assays. Donor saliva samples are also obtained for detection of CMV infection by shell-vial method.\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:b8c41f31490307111c6ab3d5876d8c72' in /persistent/html/includes/cache.inc on line 109.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f9bfbf738b23194454dc052d255ba8dc' in /persistent/html/includes/cache.inc on line 26.
user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'DISEASE CHARACTERISTICS:\n<ul>\n<li>Meets 1 of the following criteria at the City of Hope National Medical Center:\n<ul>\n<li>Patient who has undergone a matched-related or matched-unrelated allogeneic bone marrow or peripheral blood stem cell transplantation (SCT) for a hematological malignancy (e.g., aplastic anemia or myelodysplastic syndromes)\n<ul>\n<li>At risk for cytomegalovirus (CMV) infection and disease due to 1 of the following risk factors:\n<ul>\n<li>CMV-seropositive prior to transplantation</li>\n<li>Received SCT from a CMV-seropositive donor</li>\n</ul>\n</li>\n</ul>\n</li>\n<li>Donor for matched-related SCT</li>\n<li>Healthy volunteer evaluated concurrently with SCT recipients to establish normal values for both CMV-seronegative and CMV-seropositive persons</li>\n</ul>\n</li>\n<li>Any HLA serotypes allowed</li>\n</ul>\n PATIENT CHARACTERISTICS:\n<ul>\n<li>See Disease Characteristics</li>\n</ul>\n PRIOR CONCURRENT THERAPY:\n<ul>\n<li>See Disease Characteristics</li>\n</ul>\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:f9bfbf738b23194454dc052d255ba8dc' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Quantitative determination of HLA-peptide tetramer-binding assay (TBA) pp65 on days 40 and 90 after stem cell transplantation, with and without in vitro stimulation [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:a2be298ffbc5e4fe02a756ce7fe80747' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Correlation of TBApp65 results with CMV viral loads [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:8bc7e082fb2edc131888ae75091aa7eb' in /persistent/html/includes/cache.inc on line 109.
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user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = 'Correlation of TBApp65 results with CMV-associated complications [ Designated as safety issue: No ]\n', created = 1283574275, expire = 1283660675, headers = '', serialized = 0 WHERE cid = '1:ccf617847b3c12df05affe61bc3a7a64' in /persistent/html/includes/cache.inc on line 109.

Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Trial phase:

Phase II

Recruitment status:

Not yet recruiting

RATIONALE: Palifermin may help relieve or prevent oral mucositis caused by chemotherapy and radiation therapy in young patients undergoing stem cell transplant. PURPOSE: This randomized phase II trial is studying palifermin to see how well it works compared with a placebo in preventing oral mucositis caused by chemotherapy and/or radiation therapy in young patients undergoing stem cell transplant.

Background information

Trial ID:

NCT00728585

Other unique IDs:

CDR0000588622

COG-ACCL0521

Official title:

A Group-Wide Double-Blind Randomized Placebo-Controlled Trial of Palifermin to Prevent Chemotherapy and/or Radiotherapy Induced Oral Mucositis in Children Undergoing Autologous or Allogeneic Hematopoietic Stem Cell Transplantation

Detailed description:

OBJECTIVES: Primary

To compare whether palifermin versus placebo administered to pediatric patients three days prior to conditioning and three days after autologous or allogeneic hematopoietic stem cell transplantation (HSCT) is associated with a reduction in the incidence of WHO grade 3 or 4 oral mucositis.

Number to be enrolled:

200 patients

Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

Recruitment status:

Recruiting

RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.

Background information

Trial ID:

NCT00726830

Other unique IDs:

CDR0000598283

MDA-2007-0791

Official title:

A Randomized Comparison of Oral Methadone as a "First-Switch" Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The "Simply Rotate" Study

Detailed description:

OBJECTIVES: Primary

To compare the effectiveness of an opioid rotation to oral methadone versus an opioid rotation to another long-acting strong opioid (sustained-release morphine or oxycodone) in controlling pain (i.e., analgesia) in patients with cancer.

Number to be enrolled:

300 patients

Donor T Cells in Treating Patients With High-Risk Hematologic Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

Trial phase:

Phase I

Recruitment status:

Recruiting

RATIONALE: A donor peripheral stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of donor T cells may helps stop the patient's immune system from rejecting the donor's stem cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of donor T cells in treating patients with high-risk hematologic cancer who are undergoing donor peripheral blood stem cell transplant.

Background information

Trial ID:

NCT00725062

Other unique IDs:

CDR0000601051

UMN-2004LS034

MT2004-03

Official title:

MT2004-03: A Clinical Trial of Adult CD4+ CD25+ Regulatory T Cells in BMT Recipients Was "A Dose Escalation Study of CD4+ CD25+ Cells in Adult Patients Undergoing HLA-Identical Sibling Donor Peripheral Blood Progenitor Cell (PBPC) Transplantation&quo

Detailed description:

OBJECTIVES: Primary

To determine whether CD4- and CD25-positive regulatory T cells can be safely administered to patients with high-risk hematologic malignancies undergoing HLA-identical sibling donor peripheral blood progenitor cell (PBPC) transplantation.

Secondary

To determine the incidence of grade II-IV acute graft-versus-host-disease (GVHD), chronic GVHD, relapse, and survival after administration of CD4- and CD25-positive regulatory T cells in these patients.

Number to be enrolled:

32 patients

Unrelated Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

Trial phase:

Phase II

Recruitment status:

Recruiting

RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well umbilical cord blood transplant from an unrelated donor works in treating patients with hematologic cancer.

Background information

Trial ID:

NCT00723099

Other unique IDs:

CDR0000600343

FHCRC-2239.00

FHCRC-IR-6722

Official title:

Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-Intensity Preparative Regimen

Detailed description:

OBJECTIVES: Primary

To estimate probability of 1-year survival of patients with hematological malignancies undergoing a reduced-intensity preparative regimen during unrelated donor umbilical cord blood transplantation.
To demonstrate equivalent or improved engraftment rates with a nonanti-thymocyte-based conditioning regimen in patients who have not received recent chemotherapy (stratum 2).

Number to be enrolled:

60 patients

Lenalidomide Maintenance Therapy in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

The hypothesis of this study is that lenalidomide can be an effective drug in preventing relapse of MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q after allogeneic HSCT. Due to its immunomodulatory action it might also be able to enhance a T - or NK cell mediated graft versus leukemia (GVL) effects. Nevertheless, one has to keep in mind a possible, yet unknown influence on modulation of clinical GVHD.

Background information

Other unique IDs:

TUD-LENAMA-022

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

Trial phase:

Phase II

Recruitment status:

Recruiting

RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well umbilical cord blood transplant given together with cyclophosphamide, fludarabine, and total-body irradiation works in treating patients with hematologic disease.

Background information

Trial ID:

NCT00719888

Other unique IDs:

CDR0000597644

FHCRC-2010.00

Official title:

Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen

Detailed description:

OBJECTIVES: Primary

The 1-year survival of patients with hematological malignancies undergoing umbilical cord blood transplantation after a myeloablative preparative regimen comprising of cyclophosphamide, fludarabine, and fractionated total-body irradiation.

Number to be enrolled:

60 patients

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease

Trial phase:

Phase II

Recruitment status:

Active, not recruiting

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematological cancer or other disease.

Background information

Trial ID:

NCT00719849

Other unique IDs:

CDR0000597623

FHCRC-2012.00

Official title:

Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen

Detailed description:

OBJECTIVES: Primary

To estimate the probability of survival at 1 year in patients with advanced hematological malignancies or other diseases treated with non-myeloablative unrelated donor umbilical cord blood transplantation.

Number to be enrolled:

60 patients

A Phase I Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

Trial phase:

Phase I

Recruitment status:

Recruiting

This is a phase I dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced myeloid malignancies.

Background information

Trial ID:

NCT00719836

Other unique IDs:

SB1518-2007-001

Official title:

A Phase I Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

Detailed description:

Number to be enrolled:

30 patients

American Ginseng in Treating Patients With Fatigue Caused by Cancer

RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue. PURPOSE: This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.

Background information

Other unique IDs:

CDR0000597665

NCCTG-N07C2

Measuring Changes in Blood in Patients at High Risk of Cytomegalovirus Infection After Undergoing Donor Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant

Recruitment status:

Suspended

RATIONALE: Tests that measure certain changes in blood in patients at high risk of cytomegalovirus infection may help doctors learn more about predicting cytomegalovirus infection after donor stem cell transplant. PURPOSE: This clinical trial is studying tests that measure changes in the blood in patients at high risk of cytomegalovirus infection after undergoing donor bone marrow transplant or peripheral stem cell transplant.

Background information

Trial ID:

NCT00716911

Other unique IDs:

CDR0000600022

CHNMC-99061

Official title:

CMV Specific Cellular Immunity in Recipients of Allogeneic Bone Marrow Transplantation: Association of CMV-Specific HLA-Peptide Tetramer Binding With Cytotoxic T-Cell Function, CMV Infection and Other Clinical Events

Detailed description:

OBJECTIVES:

To document the quantitative characteristics of a cytomegalovirus (CMV)-specific HLA-peptide tetramer-binding assay (TBA) for cytotoxic T lymphocytes (CTLs) in patients who have undergone allogeneic bone marrow transplantation (BMT) or peripheral blood stem cell transplantation (PBSCT).
To confirm the optimal TBA conditions for CTL characterization in these patients.
To compare the TBA results for these patients with conventional assays for CTL functions.
To compare CMV-specific TBA during the first 3 months after allogeneic BMT or PBSCT and t

Number to be enrolled:

100 patients

Search clinical trials

Myelodysplastic Syndromes

Palifermin in Preventing Oral Mucositis Caused by Chemotherapy and/or Radiation Therapy in Young Patients Undergoing Stem Cell Transplant

Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer

Donor T Cells in Treating Patients With High-Risk Hematologic Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

Unrelated Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

Lenalidomide Maintenance Therapy in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease

A Phase I Study of SB1518 for the Treatment of Advanced Myeloid Malignancies

American Ginseng in Treating Patients With Fatigue Caused by Cancer

Measuring Changes in Blood in Patients at High Risk of Cytomegalovirus Infection After Undergoing Donor Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant

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