A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib and Rituximab for Previously Treated Patients with Chronic Lymphocytic Leukemia (CLL)
Furman RR, Sharman JP, Coutre SE, et al.
Key Points:
Oral inhibitor of PI3Kδ showed single agent activity against CLL in phase I trial.
In phase 3 study investigators compared rituximab + idelasib vs. rituximab + placebo in previously treated patients with CLL, PFS primary end point.
Side effects in >20%;. Grade ≥3 adverse events in ≥5% of patients were ALT elevation 6% vs 1% (experimental vs control group), anemia 6% vs 14%, neutropenia 34% vs 22%, and thrombocytopenia 10% vs 16%.
Based on efficacy and safety data, trial stopped early.
Implications:
- Combination of IDELA + R demonstrated significant improvement in PFS compared to single agent rituximab in fragile previously treated CLL patients.
View the original abstract on the ASH website.
