Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)

A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301

This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression >=6 months.

Key Inclusion Criteria:

• Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP >=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC).
• Bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension.
• Acceptable hematologic, hepatic, and renal function.

Key Exclusion Criteria:

• Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study.
• Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1.
• Transfusion-dependent subjects.
• Presence of central nervous system (CNS) lymphoma.
• Histologic transformation.
• Presence of pleural or peritoneal effusion with positive cytology for lymphoma.
• Another primary malignancy requiring active treatment.
• Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
• New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.