CLL8 — Fludarabine-Cyclophosphamide With or Without Rituximab in Previously Untreated CLL

Phase 3 · 2010 · Chronic Lymphocytic Leukemia

Design

Randomized fludarabine-cyclophosphamide (FC) vs FC plus rituximab (FCR).

Population

Previously untreated, physically fit patients with CLL.

Primary Endpoint

progression-free survival (PFS)

Key Result

Adding rituximab improved PFS and overall survival, with long-term follow-up showing durable remissions especially in IGHV-mutated disease.

Guideline Impact

Defined FCR as the historical first-line standard for fit CLL patients