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Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders conditions. Clinical Trials Search.org is a website dedicated 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 medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including 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 permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders clinical trial. Participants oftentimes recieve the finest healthcare available for their Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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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 Myelodysplastic And Myeloproliferative Disease Studies:
1. MS-275 in Treating Patients With Hematologic Cancer
2. Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies
3. VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome
4. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
5. 3-AP and Cytarabine in Treating Patients With Hematologic Cancer
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
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