Clinical Trial: NCT02947347
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Pharmacyclics LLC. |
| Information Provided By: | Pharmacyclics LLC. |
| Last Update Posted: | 2026-03-17 |
Study Overview
Brief 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).
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)
Conditions
Follicular Lymphoma
Intervention / Treatment
- Drug: Ibrutinib Oral Capsule
- Drug: Placebo
- Drug: Rituximab
Other Study ID Numbers
- PCYC-1141-CA
- 2016-003202-14
- 2023-507271-21-00
- 2023
- 2016
Start Date (Actual)
2017-01-23
Primary Completion Date (Actual)
2024-02-21
Study Completion Date (Actual)
2025-06-09
Enrollment (Actual)
445
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Pharmacyclics LLC. |
| Information Provided By: | Pharmacyclics LLC. |
| Last Update Posted: | 2026-03-17 |
Study Overview
Brief 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).
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)
Conditions
Follicular Lymphoma
Intervention / Treatment
- Drug: Ibrutinib Oral Capsule
- Drug: Placebo
- Drug: Rituximab
Other Study ID Numbers
- PCYC-1141-CA
- 2016-003202-14
- 2023-507271-21-00
- 2023
- 2016
Start Date (Actual)
2017-01-23
Primary Completion Date (Actual)
2024-02-21
Study Completion Date (Actual)
2025-06-09
Enrollment (Actual)
445
Study Type
Interventional
Phase
Phase 3