This is a Phase III, multicenter, global, clinical study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with follicular NHL. The purpose of the study is to compare the clinical benefit of galiximab when given in combination with rituximab as compared with rituximab alone (given with placebo) in subjects with follicular NHL. Safety and pharmacokinetics (PK) of galiximab and rituximab will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
340
Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4
Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4
To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS.
Time frame: The duration of this study is approx 4 years
Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival.
Time frame: The duration of this study is approx 4 years
Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies.
Time frame: The duration of this study is approx 4 years
Pharmacokinetics
Time frame: The duration of this study is approx 4 years
Quality of Life using both the Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) and the EQ-5D (EuroQoL) instruments
Time frame: The duration of this study is approx 4 years
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