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Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders Clinical research trials and Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders clinical trial. Subjects frequently obtain the most expert healthcare possible for their Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders  Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
For Condition: chronic leukemia,acute leukemia,atypical chronic myeloid leukemia,myelodysplastic and myeloproliferative disease,chronic myeloproliferative disorders
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Mycophenolate mofetil, cyclosporine, and donor white blood cells may prevent this rejection. PURPOSE: Phase I/II trial to study the effectiveness of donor stem cell transplantation in treating patients who have myelodysplastic syndrome or myeloproliferative disorder.
Details: OBJECTIVES: - Determine the efficacy of non-myeloablative allogeneic hematopoietic stem cell transplantation from related and unrelated donors in patients with myelodysplastic syndromes or myeloproliferative disorders. - Determine the safety profile of this regimen, in terms of incidence of graft-vs-host disease, graft rejection, and non-relapse mortality, in these patients. - Determine the efficacy of a strategy for donor lymphocyte infusion based primarily on defined criteria of persistent or progressive disease in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to donor status (related vs unrelated). - Conditioning:Patients receive fludarabine IV over 30 minutes once daily on days -4 to -2. Patients undergo total body irradiation on day 0. - Related Donor:Patients receive oral cyclosporine twice daily beginning on day -3 followed by a taper beginning on day 56 and continuing until day 81 or day 177 in the absence of graft-vs-host disease (GVHD). Patients also receive oral mycophenolate mofetil twice daily on days 0-27. - Unrelated Donor:Patients receive oral cyclosporine twice daily beginning on day -3 followed by a taper beginning on day 100 and continuing until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil three times daily beginning on day 0 followed by a taper beginning on day 40 and continuing until day 96. - Allogeneic Hematopoietic Stem Cell Transplantation (AHSCT): Patients undergo AHSCT transplantation on day 0. - Donor lymphocyte infusion (DLI): Eligible patients (at least mixed hematopoietic chimerism, no GVHD, and persistent or progressive disease) may receive DLI IV over 30 minutes beginning 1-2 weeks after immunosuppression. Patients may receive up to 3 infusions. Patients are followed at months 3, 4, 6, 9, 12, 18, and 24 and then annually thereafter. PROJECTED ACCRUAL: A total of 200 patients (100 per stratum) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /74 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Myelodysplastic syndromes (MDS) - Diagnosis of MDS classifiable by the FAB system as any of the following: - Refractory anemia (RA) - RA with ringed sideroblasts - RA with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - MDS transformed to acute leukemia - Patients with advanced MDS must be cytoreduced to less than 10% marrow blasts within past 21 days - High-risk disease by the International Prognostic Scoring System (IPSS) score (e.g., "intermediate-2" or "high risk") - Lower-risk disease by the IPSS score (e.g., "intermediate-1" or "low risk") allowed if evidence of progression is present (e.g., an increasing transfusion requirement) - Myeloproliferative disorders - Diagnosis of any of the following: - Atypical chronic myelogenous leukemia and Philadelphia chromosome-negative - Chronic phase - Excess blasts or blastic transformation - Polycythemia vera with persistent thrombotic or hemorrhagic complications despite conventional therapy OR progressed to post-polycythemic marrow fibrosis - Essential thrombocythemia with persistent thrombotic or hemorrhagic complications despite conventional therapy OR progressed to myelofibrosis - Agnogenic myeloid metaplasia with 1 of the following criteria: - High-risk disease according to the Lille scoring system (e.g., "intermediate" or "high risk") - Lower-risk disease according to the Lille scoring system (e.g., "low risk") with abnormal cytogenetics - Ineligible for a curative autologous transplantation - No active CNS involvement - Related donor - Genotypically or phenotypically HLA-identical - ABO incompatibility acceptable - No identical twin OR - Unrelated donor - HLA-matched for HLA-DRB1 and DQB1 - Serologic match for all recognized HLA-A, HLA-B, and HLA-C antigens - Molecular match for at least 5 of 6 HLA-A, HLA-B, or HLA-C antigens - ABO incompatibility acceptable - No bone marrow donors PATIENT CHARACTERISTICS: Age - 50 to 74 OR - Under 50 and at high risk for regimen-related toxicity using standard high-dose regimens - High-risk factors include pre-existing conditions such as chronic lung, kidney, liver, or heart disease Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - See DIsease Characteristics Hepatic - See Age - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST or ALT no greater than 4 times ULN Renal - See Age Cardiovascular - See Age - Ejection fraction at least 40% - No symptomatic congestive heart failure requiring therapy - No poorly controlled cardiac arrhythmias - No poorly controlled hypertension with inability to maintain a steady blood pressure of 150/90 Pulmonary - See Age - No requirement for supplemental oxygen - DLCO at least 50% of predicted - Total lung capacity at least 30% - FEV_1 at least 30% Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 year after study completion - HIV negative - No severe psychological illness PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent hematopoietic growth factors during mycophenolate mofetil administration Chemotherapy - At least 21 days since prior chemotherapy and recovered - Hydroxyurea or anagrilide to manage elevated cell counts allowed up until beginning of study therapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaSandmaier, Study Chair, Fred Hutchinson Cancer Research Center
Universitaet Leipzig
Leipzig, , D-04103
Germany
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Torino
Torino, , 10126
Italy
Baylor University Medical Center
Dallas, Texas, 75246
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000258519; FHCRC-1732.00
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052546
Other Chronic Leukemia Studies:
1. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
2. Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
3. 12-O-Tetradecanoylphorbol-13-acetate in Treating Patients With Hematologic Cancer or Bone Marrow Disorder
4. Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
5. Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
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Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
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