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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00445744 |
RATIONALE: Giving chemotherapy, such as cyclophosphamide and busulfan, before a donor stem cell transplant helps stop the growth of abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of cyclophosphamide and busulfan followed by donor stem cell transplant and to see how well they work in treating patients with myelofibrosis.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Chronic Myeloproliferative Disorders |
Drug: busulfan Drug: cyclophosphamide Drug: methotrexate Drug: tacrolimus Other: pharmacological study Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Cyclophosphamide Followed by Intravenous Busulfan as Conditioning for Hematopoietic Cell Transplantation in Patients With Myelofibrosis: a Phase I/II Study |
Estimated Enrollment: | 30 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, multicenter study.
After the completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No impaired pulmonary function, indicated by 1 of the following:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Andrew Rezvani, MD 206-667-1505 arezvani@fhcrc.org | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Principal Investigator: | Andrew Rezvani, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Andrew Rezvani ) |
Study ID Numbers: | CDR0000531158, FHCRC-2130.00 |
Study First Received: | March 7, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00445744 History of Changes |
Health Authority: | Unspecified |
chronic idiopathic myelofibrosis essential thrombocythemia polycythemia vera secondary myelofibrosis |
Polycythemia Antimetabolites Immunologic Factors Cyclophosphamide Tacrolimus Metaplasia Chronic Myeloproliferative Disorders Thrombocytosis Neoplasm Metastasis Thrombocythemia, Hemorrhagic Hemorrhagic Thrombocythemia Methotrexate Alkylating Agents Polycythemia Vera |
Myelofibrosis Hematologic Diseases Myeloproliferative Disorders Folic Acid Antagonists Immunosuppressive Agents Folic Acid Myeloid Metaplasia Lymphatic Diseases Busulfan Essential Thrombocytosis Antineoplastic Agents, Alkylating Bone Marrow Diseases Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Tacrolimus Cyclophosphamide Reproductive Control Agents Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |
Myelofibrosis Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Myeloid Metaplasia Lymphatic Diseases Busulfan Myeloablative Agonists Antineoplastic Agents, Alkylating Bone Marrow Diseases Antirheumatic Agents |