Tracking Information
Start Date ICMJE | December 2008 |
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Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: January 15, 2009) | progression-free-survival (PFS) [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: September 5, 2008) | median progression-free-survival (PFS) of ofatumumab added to chlorambucil therapy vs. chlorambucil therapy |
Change History | Complete list of historical versions of study NCT00748189 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: January 15, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: September 5, 2008) | clinical benefit, safety, tolerability, changes in patient reported outcome measures (PRO) and pharmacokinetics |
Descriptive Information
Brief Title ICMJE | Ofatumumab + Chlorambucil vs. Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia |
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Official Title ICMJE | A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia |
Brief Summary | The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia. |
Detailed Description | 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. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Chronic Lymphocytic Leukemia |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 444 | ||||
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Estimated Completion Date | May 2018 | ||||
Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Belgium, Czech Republic, Germany, Greece, India, Ireland, Italy, Netherlands, Poland, Russian Federation, Spain, Sweden, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00748189 | ||||
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Responsible Party | Study Director, GSK | ||||
Study ID Numbers ICMJE | OMB110911, EudraCT 2008-004932-19 | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline |