Clinical trial · Interventional
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- (Arm A) ibrutinib + rituximab
- description
- Participants to receive 560mg of ibrutinib once daily and rituximab 375mg/m\^2 weekly x4 with maintenance.
- interventionNames
- Drug: Ibrutinib Oral Capsule
- Drug: Rituximab
- type
- PLACEBO_COMPARATOR
- label
- (Arm B) placebo + rituximab
- description
- Participants to receive placebo once daily and rituximab 375mg/m\^2 weekly x4 with maintenance.
- interventionNames
- Drug: Placebo
- Drug: Rituximab
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) as Assessed by Investigator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBelada 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. PMID 42317205