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Sponsors and Collaborators: |
GlaxoSmithKline Genmab |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00748189 |
Chlorambucil, is currently approved for treatment of frontline chronic lymphocytic leukemia, especially, but not limited to the ailing and elderly patient population. Several other more aggressive treatment options are available (e.g. fludarabine), however they are not suitable for all CLL patients, especially the ailing and elderly, due to greater toxicity. Ofatumumab is effective with low toxicity. The addition of ofatumumab to chlorambucil offers potentially a more effective therapy, with limited toxicity. The objective of this study is to evaluate progression-free survival (PFS), overall response and overall survival in subjects with previously untreated CLL with ofatumumab added to chlorambucil versus chlorambucil.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia |
Drug: chlorambucil, tablets Drug: ofatumumab (GSK1841157) infusion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 444 |
Study Start Date: | September 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
GSK Clinical Trials Call Center | |
Illinois, California, United States, 60612 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | OMB110911, EudraCT 2008-004932-19 |
Study First Received: | September 5, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00748189 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
Untreated Chronic Lymphocytic Leukemia Ofatumumab |
Oncology Safety Efficacy |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Chlorambucil Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |