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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: | NCT00119340 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects and best dose of fludarabine, total-body irradiation, and donor stem cell transplant followed by cyclosporine and mycophenolate mofetil and to see how well they work in treating patients with chronic myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Fludarabine and Low-Dose TBI Dose Escalation to Determine the Optimal Regimen for Achieving High Rates Engraftment of Unrelated Donor Peripheral Blood Stem Cell in Patients With Chronic Myeloid Leukemia - A Multi-Center Trial |
Estimated Enrollment: | 75 |
Study Start Date: | April 2005 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of fludarabine and total-body irradiation (TBI).
Patients undergo TBI on day 0.
After completion of study transplantation, patients are followed 3 times weekly for 3 months, at 6, 12, and 18 months, annually for 5 years, and then periodically thereafter.
PROJECTED ACCRUAL: A total of 5-75 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
First or second chronic phase
First accelerated phase, meeting any of the following criteria:
Less than 5% blasts in marrow at time of transplant
Received prior imatinib mesylate AND meets ≥ 1 of the following criteria:
Unrelated donor available
Matched at HLA-A, -B, -C, -DRB1, and -DQB1 by high-resolution typing
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
More than 3 weeks since prior cytotoxic chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 | |
Veterans Affairs Medical Center - Seattle | |
Seattle, Washington, United States, 98108 |
Principal Investigator: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Brenda Sandmaier ) |
Study ID Numbers: | CDR0000432959, FHCRC-1939.00 |
Study First Received: | July 12, 2005 |
Last Updated: | March 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00119340 History of Changes |
Health Authority: | United States: Federal Government |
accelerated phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
Antimetabolites Philadelphia Chromosome Anti-Infective Agents Cyclosporine Immunologic Factors Hematologic Diseases Mycophenolic Acid Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Fludarabine monophosphate Immunosuppressive Agents |
Cyclosporins Anti-Bacterial Agents Leukemia Leukemia, Myeloid, Accelerated Phase Antifungal Agents Mycophenolate mofetil Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Fludarabine Antirheumatic Agents Bone Marrow Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Mycophenolic Acid Antibiotics, Antineoplastic Cyclosporins Leukemia Antifungal Agents Therapeutic Uses Mycophenolate mofetil |
Dermatologic Agents Neoplasms by Histologic Type Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Fludarabine monophosphate Leukemia, Myeloid Immunosuppressive Agents Pharmacologic Actions Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Fludarabine Bone Marrow Diseases Antirheumatic Agents |