Leukemia

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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

Lenalidomide, Fludarabine, and Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Therapy

Trial phase: 
Phase I
Recruitment status: 
Recruiting

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with fludarabine and cyclophosphamide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with fludarabine and cyclophosphamide and to see how well they work in treating patients with advanced chronic lymphocytic leukemia that did not respond to previous therapy.

Background information
Trial ID: 
NCT00727415
Other unique IDs: 
CDR0000599893
GIMEMA-LLC0606
EUDRACT-2006-006185-42
EU-20865
Official title: 

A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients.

Detailed description: 

OBJECTIVES: Primary

  • To determine the maximum tolerated dose (MTD) of lenalidomide when administered with fludarabine and cyclophosphamide in patients with advanced relapsed or refractory chronic lymphocytic leukemia. (Phase I)
  • To evaluate the complete response (CR) rate in patients treated with lenalidomide (at the MTD) in combination with fludarabine and cyclophosphamide.

Number to be enrolled: 
52 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

Clofarabine Bone Marrow Cytoreduction

Recruitment status: 
Recruiting

For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia blast percentage) at the time of HCT. This should lead to reduced relapse while still maintaining low transplant related mortality.

Background information
Trial ID: 
NCT00724009
Other unique IDs: 
15809B
Official title: 

Clofarabine Bone Marrow Cytoreduction : Feasibility of Induction as a Bridge to Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Acute Leukemias, Myelodysplastic Syndromes, and Advanced Myeloproliferative Diseases.

Detailed description: 

Screening will be done prior to enrollment in the study. The following will be done as part of the screening process:

  • Medical history review
  • Physical exam
  • Measurement of vital Signs
  • Blood tests (approximately 6 teaspoons of blood) will be done to see if the liver and kidneys are healthy, HIV (the virus that causes AIDS) test for this study and pregnancy test.
  • Urine test
  • Bone marrow biopsy and aspirate

Number to be enrolled: 
27 patients

Panobinostat in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Trial phase: 
Phase II
Recruitment status: 
Recruiting

RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how well it works in treating patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.

Background information
Trial ID: 
NCT00723203
Other unique IDs: 
CDR0000601203
CHNMC-07174
NOVARTIS-CHNMC-07174
Official title: 

A Phase II Study of LBH589, a Novel Histone Deacetylase Inhibitor, in Relapsed and Refractory Adult Patients With Acute Leukemia (AL) or in Newly Diagnosed Patients Over the Age of 60

Detailed description: 

OBJECTIVES: Primary

  • To determine the antitumor activity of panobinostat, in terms of objective response rate, time to progression, and survival, in patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.
  • To assess the toxicity of panobinostat in these patients.

Secondary

  • To perform correlative laboratory studies to assess changes in various proteins that may be altered by histone deacetylase inhibition therapy.

Number to be enrolled: 
74 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

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia.

Background information
Other unique IDs: 
CDR0000600217
COG-AALL0622

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
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