Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
Purpose
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).
Condition
- Follicular Lymphoma
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Sex
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental (Arm A) ibrutinib + rituximab |
Participants to receive 560mg of ibrutinib once daily and rituximab 375mg/m^2 weekly x4 with maintenance. |
|
|
Placebo Comparator (Arm B) placebo + rituximab |
Participants to receive placebo once daily and rituximab 375mg/m^2 weekly x4 with maintenance. |
|
More Details
- Status
- Completed
- Sponsor
- Pharmacyclics LLC.