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Sponsored by: |
Norris Comprehensive Cancer Center |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00183989 |
This study is being done in order to determine the effectiveness of the combination of fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma. All three drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U.S. Food and Drug Administration (FDA)for the treatment of certain types of lymphoma. Rituximab is a drug (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma.
The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet been investigated in patients with mantle cell lymphoma and therefore the combination in investigational.
Condition | Intervention | Phase |
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Mantle Cell Lymphoma |
Drug: Fludarabine, Mitoxantrone and Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Norris Comprehensive Cancer Center | |
Los Angeles, California, United States, 90033 |
Principal Investigator: | Alexandra M. Levine, MD | University of Southern California |
Study ID Numbers: | 13NHL-99-2 |
Study First Received: | September 12, 2005 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00183989 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antimetabolites Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Mantle-Cell Mantle Cell Lymphoma Fludarabine monophosphate Immunosuppressive Agents Lymphatic Diseases |
Fludarabine Mitoxantrone Analgesics Peripheral Nervous System Agents Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs Sensory System Agents Therapeutic Uses Analgesics Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Rituximab Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Mitoxantrone Fludarabine Peripheral Nervous System Agents Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Central Nervous System Agents |