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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Massachusetts General Hospital University of Rochester Genentech Biogen Idec |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00117156 |
The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with marginal zone or CD5-, CD10-, CD20+ low-grade B cell lymphomas.
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin MALT Lymphoma |
Drug: Fludarabine Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma |
Enrollment: | 30 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | March 2010 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
The purposes of this study are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
University of Rochester Cancer Center | |
Rochester, New York, United States, 14627 |
Principal Investigator: | Jennifer R. Brown, MD, PhD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Jennifer R. Brown, MD, PhD ) |
Study ID Numbers: | 03-294 |
Study First Received: | June 30, 2005 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00117156 History of Changes |
Health Authority: | United States: Institutional Review Board |
Fludarabine Rituximab Marginal Zone Lymphoma MALT lymphoma |
Antimetabolites Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, B-Cell, Marginal Zone Fludarabine monophosphate Immunosuppressive Agents Lymphoma, B-Cell |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases B-cell Lymphomas Fludarabine Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Physiological Effects of Drugs Lymphoma, B-Cell, Marginal Zone Fludarabine monophosphate |
Immunosuppressive Agents Pharmacologic Actions Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Fludarabine Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |