Myelodysplastic Syndromes

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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

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
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