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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00060424 |
Purpose
RATIONALE: Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. Giving chemotherapy before or after peripheral blood stem cell transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells 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 before and after the transplant may stop this from happening.
PURPOSE: This clinical trial studies how well giving fludarabine phosphate together with total-body irradiation before donor peripheral blood stem cell transplant works in treating patients with chronic lymphocytic leukemia or small lymphocytic leukemia.
| Condition | Intervention |
|---|---|
|
B-cell Chronic Lymphocytic Leukemia Contiguous Stage II Small Lymphocytic Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Prolymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage I Small Lymphocytic Lymphoma Stage II Chronic Lymphocytic Leukemia Stage II Small Lymphocytic Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Small Lymphocytic Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Small Lymphocytic Lymphoma |
Drug: fludarabine phosphate Drug: cyclosporine Drug: mycophenolate mofetil Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: hematopoietic stem cell transplantation Other: flow cytometry Genetic: polymerase chain reaction Radiation: total-body irradiation Other: laboratory biomarker analysis Procedure: bone marrow aspiration |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning for Patients With Chronic Lymphocytic Leukemia - a Multi-Center Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2003 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV on days -4 to -2 and total-body irradiation on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive oral cyclosporine every 12 hours on days -3 to 180 with taper on day 56 and oral mycophenolate mofetil every 12 hours on days 0-27.
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Drug: fludarabine phosphate
Given IV
Other Names:
Drug: cyclosporine
Given orally
Other Names:
Drug: mycophenolate mofetil
Given orally
Other Names:
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo Transplantation
Procedure: hematopoietic stem cell transplantation
Undergo Transplantation
Other Name: Stem Cell Transplantation
Other: flow cytometry
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Name: PCR
Radiation: total-body irradiation
Undergo Radiotherapy
Other Name: TBI
Other: laboratory biomarker analysis
Correlative studies
Procedure: bone marrow aspiration
Correlative studies
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PRIMARY OBJECTIVES:
I. To determine whether nonmyeloablative allogeneic HSCT from matched-related donors can improve the probability of survival 18 months after treatment for fludarabine-refractory, FCR-failed, or del 17p CLL beyond that observed in historical controls (30%).
SECONDARY OBJECTIVES:
I. To assess the rate of relapse with allogeneic HSCT using nonmyeloablative conditioning for patients with fludarabine-refractory, FCR-failed, or del 17p CLL compared with historical data on autologous HSCT.
II. To estimate the incidence of grade 2-4 acute GVHD and chronic GVHD in patients with CLL treated with low-dose TBI, fludarabine, PBSC infusion and immunosuppression with cyclosporine and mycophenylate mofetil.
III. To characterize the rate and types of infections with this regimen. IV. To estimate the rate of transplant-related mortality in the first 200 days.
OUTLINE:
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine IV on days -4 to -2 and total-body irradiation on day 0.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive oral cyclosporine every 12 hours on days -3 to 180 with taper on day 56 and oral mycophenolate mofetil every 12 hours on days 0-27.
After completion of study treatment, patients are followed up at 12 and 18 months, and then annually thereafter for 5 years.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
Contacts and Locations| United States, Washington | |
| Veterans Administration Center-Seattle | |
| Seattle, Washington, United States, 98108 | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| Italy | |
| University of Torino | |
| Torino, Italy, 10126 | |
| Principal Investigator: | David Maloney | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
| Responsible Party: | Maloney, David, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00060424 History of Changes |
| Other Study ID Numbers: | 1711.00, NCI-2010-01276 |
| Study First Received: | May 6, 2003 |
| Last Updated: | September 9, 2010 |
| Health Authority: | United States: Federal Government |
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Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Prolymphocytic Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclosporine Cyclosporins Mycophenolic Acid |
Fludarabine monophosphate Mycophenolate mofetil Vidarabine Fludarabine Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Dermatologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |