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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00002792 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Myelodysplastic/Myeloproliferative Diseases |
Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS |
Estimated Enrollment: | 20 |
Study Start Date: | June 1996 |
Study Completion Date: | April 2003 |
Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive a preparative regimen consisting of oral busulfan every 6 hours on days -7 through -4 and cyclophosphamide on days -3 and -2. Patients then receive allogeneic bone marrow or peripheral blood stem cells on day 0. Patients registered on protocol FHCRC-1106.00 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem cells from an HLA-identical donor.
Patients receive cyclosporine/methotrexate or tacrolimus/methotrexate as prophylaxis for graft-versus-host disease (GVHD). Patients receiving marrow from unrelated donors are eligible for appropriate GVHD prophylaxis studies.
Patients are followed at 6 and 12 months after transplant.
PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study over approximately 3.5 years.
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Idiopathic myelofibrosis (IMF) with at least 1 poor prognosis characteristic, including but not limited to:
No evidence of leukemic progression, e.g.:
No other causes for myelofibrosis, such as:
One of the following donor/patient pairings is required:
Donor status:
Genotypic or phenotypic HLA-matched relative
One antigen HLA-mismatched relative, HLA-matched unrelated donor, or one antigen HLA-mismatched unrelated donor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Study Chair: | H. Joachim Deeg, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000064859, FHCRC-1032.01, NCI-H96-0929 |
Study First Received: | November 1, 1999 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00002792 History of Changes |
Health Authority: | United States: Federal Government |
polycythemia vera chronic idiopathic myelofibrosis essential thrombocythemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable |
Antimetabolites Polycythemia Anti-Infective Agents Cyclosporine Immunologic Factors Folate Cyclophosphamide Tacrolimus Cyclosporins Vitamin B9 Leukemia Antifungal Agents Metaplasia Chronic Myeloproliferative Disorders Thrombocytosis |
Thrombocythemia, Hemorrhagic Hemorrhagic Thrombocythemia Methotrexate Alkylating Agents Myelodysplastic Myeloproliferative Disease Polycythemia Vera Myelofibrosis Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myeloproliferative Disorders Leukemia, Myeloid Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Folic Acid |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Cyclophosphamide Tacrolimus Cyclosporins Leukemia Pathologic Processes Antifungal Agents |
Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Disease Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions |