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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: | NCT00110058 |
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor peripheral blood 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). Giving an infusion of the donor's T cells (donor lymphocyte infusion) or interferon alfa after the transplant may help increase this 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 the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with radiation therapy works in treating patients who are undergoing donor stem cell transplant for chronic phase or accelerated phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: cyclosporine Drug: fludarabine phosphate Drug: imatinib mesylate Drug: mycophenolate mofetil Drug: recombinant interferon alfa Drug: therapeutic allogeneic lymphocytes Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multi-Center Phase II Study of Nonmyeloablative Conditioning With TBI and Fludarabine for HLA-Matched Related Hematopoietic Cell Transplantation for Treatment of Chronic Myeloid Leukemia in Chronic and Accelerated Phase |
Estimated Enrollment: | 40 |
Study Start Date: | February 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed at 6, 9, 12, 18, and 24 months, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting 1 of the following criteria:
Chronic phase
Accelerated phase, meeting any of the following criteria:
Failed OR suboptimal response to prior imatinib mesylate, as defined by 1 of the following:
Absence of cytogenetic response, as defined by 1 of the following:
Cytogenetic evidence of disease progression
Molecular evidence of disease progression
HLA identical related donor available
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 |
Principal Investigator: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000423314, FHCRC-1954.00 |
Study First Received: | May 3, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00110058 |
Health Authority: | United States: Federal Government |
accelerated phase chronic myelogenous leukemia childhood chronic myelogenous leukemia chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
Philadelphia Chromosome Interferon-alpha Interferon Type I, Recombinant Cyclosporine Chronic myelogenous leukemia Clotrimazole Hematologic Diseases Miconazole Interferons Tioconazole Myeloproliferative Disorders Fludarabine monophosphate |
Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Cyclosporins Imatinib Leukemia Leukemia, Myeloid, Accelerated Phase Mycophenolate mofetil Leukemia, Myelogenous, Chronic, BCR-ABL Positive Fludarabine Bone Marrow Diseases Interferon Alfa-2a |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Antifungal Agents Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Antirheumatic Agents Dermatologic Agents |