Description:
The purpose of this study is to evaluate whether the addition of ibrutinib will result in
prolongation of progression-free survival (PFS) when compared with rituximab alone in
treatment naïve subjects with follicular lymphoma.
Title
- Brief Title: Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
- Official Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
PCYC-1141-CA
- NCT ID:
NCT02947347
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ibrutinib | Imbruvica | (Part 1 : Arm A) ibrutinib + rituximab |
placebo to match ibrutinib | | (Part 1 : Arm B) placebo + rituximab |
rituximab | | (Part 1 : Arm A) ibrutinib + rituximab |
ibrutinib | Imbruvica | (Part 2 : Arm A1) ibrutinib |
placebo to match ibrutinib | | (Part 2 : Arm A2) placebo |
Purpose
The purpose of this study is to evaluate whether the addition of ibrutinib will result in
prolongation of progression-free survival (PFS) when compared with rituximab alone in
treatment naïve subjects with follicular lymphoma.
Trial Arms
Name | Type | Description | Interventions |
---|
(Part 1 : Arm A) ibrutinib + rituximab | Experimental | Subjects will receive 560mg of ibrutinib and rituximab 375mg/m^2 weekly x4 with maintenance.
In Part 1, Arm A to Arm B ratio is 3:1 | |
(Part 1 : Arm B) placebo + rituximab | Placebo Comparator | Subjects will receive placebo and rituximab 375mg/m^2 weekly x4 with maintenance.
In Part 1, Arm A to Arm B ratio is 3:1 | - placebo to match ibrutinib
- rituximab
|
(Part 2 : Arm A1) ibrutinib | Experimental | Subjects will receive 560mg of ibrutinib
Part 1 Arm A subjects will be re-randomized 1:1 into Part 1 Arm A1 or Arm A2 | |
(Part 2 : Arm A2) placebo | Placebo Comparator | Subjects will receive placebo
Part 1 Arm A subjects will be re-randomized 1:1 into Part 2 Arm A1 or Arm A2 | - placebo to match ibrutinib
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 60 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival |
Time Frame: | 2-5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Response Rate (ORR) |
Time Frame: | 2-5 years |
Safety Issue: | |
Description: | Part 1 |
Measure: | Overall Survival |
Time Frame: | 2-5 years |
Safety Issue: | |
Description: | Part 1 |
Measure: | Infusion-Related Reaction Rate |
Time Frame: | 2-5 years |
Safety Issue: | |
Description: | Arm A vs. Arm B (Part 1) |
Measure: | Adverse Events |
Time Frame: | 2-5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Pharmacyclics LLC. |
Last Updated
July 21, 2021