E1912 — Ibrutinib-Rituximab Versus Chemoimmunotherapy (FCR) in Younger Patients With Untreated CLL

Phase 3 · 2019 · Chronic Lymphocytic Leukemia

Design

Randomized 2:1 to ibrutinib plus rituximab vs fludarabine, cyclophosphamide, and rituximab (FCR).

Population

Untreated CLL in patients 70 years or younger, without del(17p).

Primary Endpoint

progression-free survival (PFS)

Key Result

Superior PFS and overall survival with ibrutinib-rituximab vs FCR (3-yr PFS 89.4% vs 72.9%).

Guideline Impact

Supported first-line BTK-inhibitor therapy as preferred over FCR in NCCN guidelines