Phase 3
N=445
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02947347 ↗Enrolled (actual)
445
Serious AEs
58.9%
Results posted
Mar 2026
Primary outcome: Primary: Progression-Free Survival (PFS) as Assessed by Investigator — 42.02; 32.76 months — p=0.0231
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ibrutinib Oral Capsule (Drug); Placebo (Drug); Rituximab (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Pharmacyclics LLC.
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) as Assessed by Investigator |
42.02; 32.76 | 0.0231 sig |
| SECONDARY Overall Response Rate (ORR) as Assessed by Investigator |
81.4; 68.5 | 0.0040 sig |
| SECONDARY Overall Survival (OS) |
NA; 78.98 | 0.6608 |
| SECONDARY Infusion-related Reaction Rate Assessed by Investigator |
21.3; 27.0 | 0.2087 |
| SECONDARY Duration of Response (DOR) as Assessed by Investigator |
44.25; 34.56 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
324; 106; 259; 63; 204; 45 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02947347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.