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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052546 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: therapeutic allogeneic lymphocytes Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation For The Treatment Of Myelodysplatic Syndromes And Myeloproliferative Disorders (Except CML): A Multi-Center Trial |
| Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to donor status (related vs unrelated).
Immunosuppression:
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| Ages Eligible for Study: | up to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Myelodysplastic syndromes (MDS)
Diagnosis of MDS classifiable by the FAB system as any of the following:
High-risk disease by the International Prognostic Scoring System (IPSS) score (e.g., "intermediate-2" or "high risk")
Myeloproliferative disorders
Diagnosis of any of the following:
Atypical chronic myelogenous leukemia and Philadelphia chromosome-negative
Agnogenic myeloid metaplasia with 1 of the following criteria:
Related donor
Unrelated donor
PATIENT CHARACTERISTICS:
Age
Under 50 and at high risk for regimen-related toxicity using standard high-dose regimens
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 21 days since prior chemotherapy and recovered
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Germany | |
| Universitaet Leipzig | |
| Leipzig, Germany, D-04103 | |
| Italy | |
| University of Torino | |
| Torino, Italy, 10126 | |
| Study Chair: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000258519, FHCRC-1732.00 |
| Study First Received: | January 24, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052546 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory anemia with excess blasts in transformation refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia chronic myelomonocytic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes chronic phase chronic myelogenous leukemia Philadelphia chromosome negative chronic myelogenous leukemia |
polycythemia vera essential thrombocythemia chronic idiopathic myelofibrosis blastic phase chronic myelogenous leukemia chronic eosinophilic leukemia chronic neutrophilic leukemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable childhood myelodysplastic syndromes |
|
Antimetabolites Polycythemia Philadelphia Chromosome Chronic Myelomonocytic Leukemia Blast Crisis Cyclosporine Immunologic Factors Precancerous Conditions Leukemia, Myeloid, Chronic-Phase Cyclosporins Refractory Anemia Leukemia Preleukemia Anemia, Refractory Antifungal Agents |
Chronic Myeloproliferative Disorders Mycophenolate mofetil Neoplasm Metastasis Thrombocytosis Hemorrhagic Thrombocythemia Thrombocythemia, Hemorrhagic Myelodysplastic Myeloproliferative Disease Polycythemia Vera Myelofibrosis Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myeloproliferative Disorders Anemia |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Precancerous Conditions Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclosporins Leukemia Preleukemia Pathologic Processes Therapeutic Uses Syndrome |
Antifungal Agents Mycophenolate mofetil Dermatologic Agents Neoplasms by Histologic Type Disease Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Neoplasms Fludarabine Antirheumatic Agents |