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
- 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
- Bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single
- 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
- 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.