Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
Phase 3
Terminated
- Conditions
- Lymphoma, Non-Hodgkin's
- Registration Number
- NCT00384150
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies Study period is approx. 2 years
- Secondary Outcome Measures
Name Time Method 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