Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
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.
- Treatment Naive Follicular Lymphoma
- Eligible Ages
- Over 60 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- Transformed lymphoma
- Prior treatment for follicular lymphoma
- Central nervous system lymphoma or leptomeningeal disease
- Currently active, clinically significant cardiovascular disease
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
(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||
(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||
(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||
(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||
(Part 2 : Arm B) placebo
|Subjects will receive placebo Part 1 Arm B subjects will be re-randomized into Part 2 Arm B||
- Pharmacyclics LLC.
Study ContactSilvie Aarts
+1- 669- 224- 1860