Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Phase 3 Completed 445 enrolled Pharmacyclics LLC. Janssen Research & Development, LLC · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve participants with follicular lymphoma (FL).

Timeline

Start: 2017-01-23
Primary completion: 2024-02-21
Completion: 2025-06-09

Outcome

Met primary endpoint

paper PFS was significantly improved with ibrutinib + rituximab versus placebo + rituximab PMID 42317205 ↗

paper hazard ratio, 0.713 [95% CI, 0.532-0.955]; P = 0.0231; median 42.0 vs. 32.8 months PMID 42317205 ↗

Publications

Belada D, Gardner FP, de Oliveira AC, Sancho JM, Lomaia E, Wright D, Turgut M, Martynova E, Lazar Z, Anz B, Wang MC, Legiec W, Opat S, Pailden J, Peltier HM, Marturano E, Dean JP, Flinn IW. Phase 3 PERSPECTIVE study: Ibrutinib with rituximab for initial treatment of patients with follicular lymphoma. Hemasphere. 2026 Jun 17;10(6):e70400. doi: 10.1002/hem3.70400. eCollection 2026 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	560 mg	Oral
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous