PCYC-1141-CA (PERSPECTIVE) (FL)

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)

Study Treatments

Part 1:

• Arm A: 560 mg of ibrutinib + rituximab 375 mg/m² weekly x4 with maintenance
• Arm B: placebo + rituximab 375 mg/m² weekly x4 with maintenance

Part 2:

• Arm A1: 560 mg of ibrutinib
• Arm A2: placebo
• Arm B: placebo

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
• ECOG score 0-2

Exclusion criteria

• Transformed lymphoma
• Prior treatment for follicular lymphoma
• Central nervous system lymphoma or leptomeningeal disease
• Currently active, clinically significant cardiovascular disease

Participating sites

• AZ St-Jan Brugge-Oostende
• Cliniques Universitaires UCL Saint Luc
• ZNA