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

Biogen0 sites16 target enrollmentNovember 2007

ConditionsLymphoma, Non-Hodgkin's

Drugsgaliximab in combination with rituximab

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Lymphoma, Non-Hodgkin's
Sponsor: Biogen
Enrollment: 16
Primary Endpoint: Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

January 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

Eligibility Criteria

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.

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
•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.

Outcomes

Primary Outcomes

Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies

Time Frame: Study period is approx. 2 years

Secondary Outcomes

Pharmacokinetics(Study period is approx. 2 years)
To further characterize the efficacy profile of galiximab in combination with rituximab(Study period is approx. 2 years)