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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00278161 |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating leukemia or non-Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Biological: pegfilgrastim Biological: rituximab Drug: cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of High Dose Cyclophosphamide and Rituximab in Low Grade and Mantle Cell Lymphoma |
Estimated Enrollment: | 32 |
Study Start Date: | January 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive rituximab IV over 30-60 minutes on days 1, 4, 8,11, 45, and 52, cyclophosphamide IV over 1 hour on days 15-18, and pegfilgrastim subcutaneously on day 19 or 20 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 32 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:
One of the following B-cell leukemias or lymphomas, as defined by World Health Organization criteria:
No more than minimal (approximately 10%) morphologically identifiable cancer cells on bone marrow biopsy
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | Lode J. Swinnen, MD | Sidney Kimmel Comprehensive Cancer Center |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Lode J. Swinnen ) |
Study ID Numbers: | CDR0000451458, JHOC-J0260, JHOC-03022409 |
Study First Received: | January 16, 2006 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00278161 History of Changes |
Health Authority: | Unspecified |
stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia small lymphocytic lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma B-cell chronic lymphocytic leukemia splenic marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma stage I grade 1 follicular lymphoma stage I 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 stage I mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma Waldenstrom macroglobulinemia prolymphocytic leukemia stage I marginal zone lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II mantle cell lymphoma contiguous stage II marginal zone lymphoma |
Leukemia, Lymphoid Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Cyclophosphamide Follicular Lymphoma Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Leukemia, Prolymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Alkylating Agents |
Lymphoma Immunoproliferative Disorders Prolymphocytic Leukemia Rituximab Immunosuppressive Agents Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Chronic Lymphocytic Leukemia B-cell Lymphomas Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Lymphoma, Mantle-Cell Physiological Effects of Drugs Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Alkylating Agents Lymphoma |