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Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

NCT02947347 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2026-03-17

Study results available
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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).

Conditions

Interventions

DRUG

Ibrutinib Oral Capsule

Ibrutinib 560mg administered orally daily

DRUG

Placebo

Placebo capsules to match ibrutinib administered orally daily

DRUG

Rituximab

Rituximab 375mg/m\^2 intravenously (IV) weekly

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Pharmacyclics LLC.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2024-02-21
Completion
2025-06-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Greece
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02947347 on ClinicalTrials.gov