CompletedPhase 3

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

United States445 participantsStarted 2017-01-23

Plain-language 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).

Who can participate

Age range60 Years

SexALL

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Inclusion Criteria: * Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease. * Measurable disease * Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities. * Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria. * Adequate hematologic function within protocol-defined parameters. * Adequate hepatic and renal function within protocol-defined parameters. * ECOG performance status score of 0-2. Exclusion Criteria: * Transformed lymphoma * Prior treatment for follicular lymphoma. * Central nervous system lymphoma or leptomeningeal disease. * Currently active, clinically significant cardiovascular disease.

What they're measuring

Progression-Free Survival (PFS) as Assessed by Investigator

Timeframe: Primary Analysis cut-off; median overall follow-up of 53.75 months

Trial details

NCT IDNCT02947347

SponsorPharmacyclics LLC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-21

Results submitted2026-02-24

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