MURANO — A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia

Phase 3 · 2018 · Chronic Lymphocytic Leukemia

Design

Open-label randomized trial of fixed-duration (24-month) venetoclax plus rituximab versus six cycles of bendamustine-rituximab.

Population

Adults with relapsed or refractory CLL after 1-3 prior therapies.

Primary Endpoint

investigator-assessed progression-free survival (PFS)

Key Result

Final 7-year analysis: median PFS 54.7 vs 17.0 mo; 7-year OS 69.6% vs 51.0%; deep, durable uMRD after fixed-duration therapy.

Guideline Impact

NCCN category 1 for relapsed/refractory CLL