Phase 3
Completed N=445
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Source: ClinicalTrials.gov NCT02947347 ↗Enrolled (actual)
445
Serious AEs
58.9%
Results posted
Mar 2026
Primary outcomePrimary: Progression-Free Survival (PFS) as Assessed by Investigator — 42.02; 32.76 months — p=0.0231
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 | — |
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. Informational only — not medical advice.