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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052923 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether stem cell transplantation is more effective with or without rituximab in treating relapsed or progressive B-cell diffuse large cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: filgrastim Drug: rituximab Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase III Trial Of Rituximab (NSC #687451) And Autologous Stem Cell Transplantation For B Cell Diffuse Large Cell Lymphoma |
Estimated Enrollment: | 427 |
Study Start Date: | March 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to relapse (relapsed more than 6 months after either initial complete remission [CR] or CR with positive positron emission tomography or MRI [gallium] vs failed to achieve initial CR or relapsed within 6 months after either initial CR or CR with positive PET or MRI [gallium]) and prior rituximab (yes vs no).
Stem cell mobilization
Preparative regimen
Stem cells are reinfused on day 0. Patients are then randomized to one of two post-transplant treatment arms.
Post-transplant treatment
PROJECTED ACCRUAL: A total of 427 patients will be accrued for this study within 3.5 years.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of diffuse large cell lymphoma and meeting the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 3 prior chemotherapy regimens
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Ian W. Flinn, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
Study Chair: | Charles A. Linker, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000258802, ECOG-E2499, CALGB-50205, CALGB-E2499 |
Study First Received: | January 24, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00052923 |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Carmustine Cyclophosphamide Etoposide phosphate Recurrence Lymphoma, B-Cell |
Lymphoma, large-cell Lymphatic Diseases B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Etoposide Lymphoma |
Neoplasms by Histologic Type Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |