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

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Biogen
• Treatments: Antibodies, Monoclonal; Galiximab; Rituximab

Criteria

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.