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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00748189 |
The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia |
Drug: ofatumumab (GSK1841157) infusion Drug: chlorambucil, tablets |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, 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: | December 2008 |
Estimated Study Completion Date: | May 2018 |
Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ofatumumab + chlorambucil: Experimental
ofatumumab dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles
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Drug: ofatumumab (GSK1841157) infusion
iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;
Drug: chlorambucil, tablets
2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
|
chlorambucil: Active Comparator
chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
|
Drug: chlorambucil, tablets
2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | OMB110911, EudraCT 2008-004932-19 |
Study First Received: | September 5, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00748189 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Untreated Chronic Lymphocytic Leukemia Ofatumumab |
Oncology Safety Efficacy |
Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell |
Chlorambucil Antineoplastic Agents, Alkylating Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell Alkylating Agents |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Chlorambucil Pharmacologic Actions Leukemia |
Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Antineoplastic Agents, Alkylating Leukemia, B-Cell Lymphoproliferative Disorders Alkylating Agents |