Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02947347 |
Recruitment Status :
Active, not recruiting
First Posted : October 27, 2016
Last Update Posted : September 9, 2022
|
Sponsor:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Pharmacyclics LLC.
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | October 26, 2016 | ||||
First Posted Date ICMJE | October 27, 2016 | ||||
Last Update Posted Date | September 9, 2022 | ||||
Actual Study Start Date ICMJE | January 2017 | ||||
Estimated Primary Completion Date | June 2026 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: 2-5 years ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma | ||||
Official Title ICMJE | 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) | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
||||
Condition ICMJE | Follicular Lymphoma | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
431 | ||||
Original Estimated Enrollment ICMJE |
440 | ||||
Estimated Study Completion Date ICMJE | June 2026 | ||||
Estimated Primary Completion Date | June 2026 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, Czechia, France, Greece, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02947347 | ||||
Other Study ID Numbers ICMJE | PCYC-1141-CA 2016-003202-14 ( EudraCT Number ) |
||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Pharmacyclics LLC. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Pharmacyclics LLC. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Pharmacyclics LLC. | ||||
Verification Date | September 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |