ECOG 1496 — Maintenance Rituximab After Cyclophosphamide, Vincristine, and Prednisone Prolongs Progression-Free Survival in Advanced Indolent Lymphoma: Results of the Randomized Phase III ECOG1496 Study

Phase 3 · 2009 · Follicular Lymphoma, Indolent Non-Hodgkin Lymphoma

Design

Randomized phase III trial in which patients responding to induction CVP were randomly assigned to maintenance rituximab or observation.

Population

311 patients with advanced (stage III/IV) indolent/follicular non-Hodgkin lymphoma who had at least stable disease after CVP induction chemotherapy.

Primary Endpoint

Progression-free survival

Key Result

Maintenance rituximab markedly prolonged progression-free survival (4.8 years vs 1.3 years; HR 0.4, P<.0001) and improved overall survival (HR 0.4) versus observation.

Guideline Impact

Supported rituximab maintenance following induction in indolent/follicular lymphoma guidelines.