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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: | NCT00104858 |
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 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 lymphocytic leukemia or small lymphocytic lymphoma that did not respond to fludarabine.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Nonmyeloablative Conditioning Followed By Unrelated Donor Hematopoietic Cell Transplantation For Patients With Fludarabine-Refractory Chronic Lymphocytic Leukemia: A Multi-Center Trial |
Estimated Enrollment: | 40 |
Study Start Date: | December 2004 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed at 6 months, 1 year, and then annually thereafter.
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 chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, as defined by all of the following criteria:
B-Cell CLL or PLL patients who:
have de novo of acquired "17p deletion" cytogenetic abnormality
Suitable unrelated donor available
Matched for 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
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: David G. Maloney, MD, PhD 206-667-5616 dmaloney@fhcrc.org | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |
Veterans Affairs Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98108 | |
Contact: Thomas R. Chauncey, MD, PhD 206-762-1010 |
Principal Investigator: | David G. Maloney, MD, PhD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( David G. Maloney ) |
Study ID Numbers: | CDR0000415556, FHCRC-1840.00 |
Study First Received: | March 3, 2005 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00104858 History of Changes |
Health Authority: | Unspecified |
refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma B-cell chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia prolymphocytic leukemia |
Antimetabolites Leukemia, Lymphoid Cyclosporine Immunologic Factors Large Granular Lymphocyte Leukemia Clotrimazole Miconazole Cyclosporins Leukemia Leukemia, Prolymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Antifungal Agents Mycophenolate mofetil Leukemia, B-cell, Chronic |
Lymphoma Prolymphocytic Leukemia Immunoproliferative Disorders Tioconazole Fludarabine monophosphate Immunosuppressive Agents Recurrence Lymphatic Diseases Chronic Lymphocytic Leukemia Fludarabine Antirheumatic Agents Lymphoproliferative Disorders Leukemia, B-Cell |
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclosporins Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Antifungal Agents Therapeutic Uses Mycophenolate mofetil |
Dermatologic Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine Antirheumatic Agents Lymphoproliferative Disorders Leukemia, B-Cell |