Status:
TERMINATED
Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Biogen
Conditions:
Lymphoma, Non-Hodgkin's
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 r...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00384150
Start Date
November 1 2007
End Date
January 1 2010
Last Update
November 26 2015
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