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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00425802 |
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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 rituximab before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy and radiation therapy together with rituximab and donor stem cell transplant works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: filgrastim Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: rituximab Procedure: graft-versus-tumor induction therapy Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Hematopoietic Stem Cells From HLA-Compatible Related or Unrelated Donors in Patients With B Cell Lymphoid Malignancies |
Estimated Enrollment: | 60 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to donor type (HLA-matched related vs HLA-matched unrelated or single HLA allele-disparate related or unrelated).
NOTE: *Patients with HLA-matched sibling donors do not receive ATG.
After completion of study treatment, patients are followed every 3-6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
CD20-positive aggressive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
Diffuse large cell lymphoma*, meeting 1 of the following criteria:
Large cell transformation of indolent NHL or chronic lymphocytic leukemia (CLL), meeting the following criteria:
Mantle cell lymphoma*, meeting 1 of the following criteria:
CD20-positive indolent NHL (e.g., follicular lymphoma, small cell lymphoma, or marginal zone NHL) OR CLL
Must have received pre-allograft salvage chemotherapy, including 1 of the following:
HLA-compatible related or unrelated donor available
HLA-matched ≥ 9/10 of the A, B, C, DRB1, and DQB1 loci, as tested by high resolution typing
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Hugo R. Castro-Malaspina, MD 212-639-8197 |
Principal Investigator: | Hugo R. Castro-Malaspina, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Juliet Barker, MBBS | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Craig Moskowitz, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Hugo R. Castro-Malaspina ) |
Study ID Numbers: | CDR0000525951, MSKCC-06150 |
Study First Received: | January 19, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00425802 |
Health Authority: | Unspecified |
noncontiguous stage II adult diffuse large cell lymphoma recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma B-cell chronic lymphocytic leukemia refractory chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia noncontiguous stage II mantle cell lymphoma recurrent mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma recurrent grade 1 follicular lymphoma |
recurrent grade 2 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma noncontiguous stage II small lymphocytic lymphoma recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma noncontiguous stage II marginal zone lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma |
Leukemia, Lymphoid Cyclosporine Clotrimazole Miconazole Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Cyclophosphamide Cyclosporins Lymphoma, large-cell, immunoblastic Lymphoma, B-Cell Lymphoma, large-cell Leukemia Leukemia, Lymphocytic, Chronic, B-Cell |
Lymphoma, Large-Cell, Immunoblastic Mycophenolate mofetil Lymphoma Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Tioconazole Fludarabine monophosphate Mantle cell lymphoma Recurrence Antilymphocyte Serum Lymphatic Diseases B-cell lymphomas |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Antifungal Agents Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |