Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
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ClinicalTrials.gov Identifier: NCT00384150
Recruitment Status :
(Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.)
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.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Presence of central nervous system (CNS) lymphoma.
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.