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Sponsors and Collaborators: |
University of Pittsburgh Genentech Biogen Idec |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00280241 |
This research study will look at the effects (good or bad) of administering cyclophosphamide, fludarabine, and rituximab. Clinical studies with combination therapy have shown higher response rates than using single drugs, and this study will evaluate the side effects and effectiveness of this combination.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia |
Drug: Fludarabine Drug: Cyclophosphamide Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 60 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | June 2009 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
This study is designed to expand on the highly successful combination of rituximab, fludarabine and cyclophosphamide for patients with previously untreated CLL. Responses in the range of 90-98% with 55% complete responses are reported. However, bone marrow toxicity has been a significant problem.
This trial is designed to reduce the bone marrow toxicity by decreasing the doses of fludarabine and cyclophosphamide, but doubling the dose of rituximab with a maintenance dose of rituximab for up to two years, to maintain or even enhance efficacy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
United States, Pennsylvania | |
Hillman Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | Suzanne Lentzsch, MD, PhD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Cancer Institute ( Dr. Kenneth A. Foon ) |
Study ID Numbers: | 03-136 |
Study First Received: | January 19, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00280241 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic Lymphocytic Leukemia |
Fludarabine Cyclophosphamide Rituximab |
Antimetabolites Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Cyclophosphamide Fludarabine monophosphate Immunosuppressive Agents Leukemia Lymphatic Diseases |
Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Alkylating Agents |
Antimetabolites Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Rituximab Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Leukemia, B-Cell Antirheumatic Agents |