At a glance
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A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib Versus Chlorambucil Plus Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia
In Brief
A Phase 3 clinical trial evaluating Acalabrutinib, Rituximab, and 1 other intervention for Untreated Chronic Lymphocytic Leukemia. Active but no longer recruiting, targeting 155 participants across 46 sites in 5 countries.
Signals
Detailed Summary
This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of Acalabrutinib versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
Study Details
Timeline
Arms & Interventions
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity
Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles
Interventions
acalabrutinib 100 mg twice daily orally
Rituximab: 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
Chlorambucil: 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6