Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
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ClinicalTrials.gov Identifier: NCT02947347 |
Recruitment Status :
Active, not recruiting
First Posted : October 27, 2016
Last Update Posted : September 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Follicular Lymphoma | Drug: ibrutinib Drug: placebo to match ibrutinib Drug: rituximab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 431 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | January 2017 |
Estimated Primary Completion Date : | June 2026 |
Estimated Study Completion Date : | June 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: (Part 1 : Arm A) ibrutinib + rituximab
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 |
Drug: ibrutinib
ibrutinib 560mg administered orally
Other Name: Imbruvica Drug: rituximab rituximab 375mg/m^2 IV |
Placebo Comparator: (Part 1 : Arm B) placebo + rituximab
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 |
Drug: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally Drug: rituximab rituximab 375mg/m^2 IV |
Experimental: (Part 2 : Arm A1) ibrutinib
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 |
Drug: ibrutinib
ibrutinib 560mg administered orally
Other Name: Imbruvica |
Placebo Comparator: (Part 2 : Arm A2) placebo
Subjects will receive placebo Part 1 Arm A subjects will be re-randomized 1:1 into Part 2 Arm A1 or Arm A2 |
Drug: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally |
- Progression-free survival [ Time Frame: 2-5 years ]
- Overall Response Rate (ORR) [ Time Frame: 2-5 years ]Part 1
- Overall Survival [ Time Frame: 2-5 years ]Part 1
- Infusion-Related Reaction Rate [ Time Frame: 2-5 years ]Arm A vs. Arm B (Part 1)
- Adverse Events [ Time Frame: 2-5 years ]

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947347

Responsible Party: | Pharmacyclics LLC. |
ClinicalTrials.gov Identifier: | NCT02947347 |
Other Study ID Numbers: |
PCYC-1141-CA 2016-003202-14 ( EudraCT Number ) |
First Posted: | October 27, 2016 Key Record Dates |
Last Update Posted: | September 9, 2022 |
Last Verified: | September 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |