Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

• Status: Active, not recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.
• Treatments: Rituximab

Criteria

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