CLL14 — A Study of Venetoclax Plus Obinutuzumab Versus Chlorambucil Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia and Coexisting Medical Conditions

Phase 3 · 2019 · Chronic Lymphocytic Leukemia

Design

Open-label randomized trial of 12 months fixed-duration venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab.

Population

Previously untreated CLL patients with coexisting conditions (CIRS >6 and/or reduced creatinine clearance).

Primary Endpoint

investigator-assessed progression-free survival (PFS)

Key Result

2-year PFS 88.2% vs 64.1% (HR 0.35); high rates of undetectable MRD and durable PFS after treatment cessation.

Guideline Impact

NCCN category 1 / preferred frontline option for CLL