SHS_492375 PAGJ CPCY 17024

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

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.

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
Phase III
NCT02947347
Cancer, All Other
Hematologic
John Pagel, M.D.
Pharmacyclics
Neil Bailey
  • Swedish Medical Center