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Sponsors and Collaborators: |
Biogen Idec Hoffmann-La Roche Genentech |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00090051 |
The purpose of this study is to provide treatment for patients who have CLL, and to compare the use of rituximab added to FC with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia |
Drug: Rituxan® |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-Cell CLL |
Estimated Enrollment: | 550 |
Study Start Date: | June 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 102-14 |
Study First Received: | August 23, 2004 |
Last Updated: | September 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00090051 |
Health Authority: | United States: Food and Drug Administration |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Rituximab Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |