At a glance
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A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL
In Brief
A Phase 2 clinical trial evaluating Rituximab, Bendamustine, and 1 other intervention for Chronic Lymphocytic Leukemia (CLL). Completed, enrolled 183 participants across 54 sites in 8 countries.
Detailed Summary
The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.
Study Details
Timeline
Interventions
Rituximab was administered by IV infusion as a dose of 375 mg/m\^2 on Day 2 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycles
Bendamustine was administered by IV infusion as a dose of 70 mg/m\^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.
MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.