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

Biogen

Status and phase

Terminated

Phase 3

Conditions

Lymphoma, Non-Hodgkin's

Treatments

Drug: galiximab in combination with rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00384150

114-NH-302

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.