A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Randomized, Double-Blind Study of Galiximab in Combination With Rituximab Compared With Rituximab in Combination With Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin's Lymphoma

Conditions
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Lymphoma, Non-Hodgkin's

Intervention / Treatment
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* Drug: Galiximab in combination with rituximab
* Drug: Rituximab in combination with placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Key Inclusion Criteria: Aged >= 18 years old at the time of informed consent. Histologically confirmed follicular Grade 1-3a NHL. Relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment. Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension. Acceptable hematologic, hepatic, and renal function parameters. Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs. Key Exclusion Criteria: Follicular lymphoma Grade 3b. Rituximab refractory or refractory to anti-CD20 radioimmunotherapy (no response to prior rituximab or prior rituximab-containing regimen, or a response with a TTP of less than 6 months). Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to Study Day 1 (6 weeks if nitrosourea or mitomycin C). Prior lymphoma vaccine therapy within 12 months prior to Study Day 1. Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to Study Day 1. Autologous bone marrow or stem cell transplant within 6 months prior to Study Day 1. Prior allogeneic transplant. Transfusion-dependent subjects. Another primary malignancy requiring active treatment (except hormonal therapy). Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions, which 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Galiximab in combination with rituximab<br>* Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4<br>|
| Active Comparator: 2<br> | Drug: Rituximab in combination with placebo<br>* Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess efficacy as measured by progression free survival (PFS), and determine whether rituximab plus galiximab compared to rituximab plus placebo may extend PFS. |  | The duration of this study is approx 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy measures include: event-free survival, time to progression, duration of response, complete response rate, and overall survival. |  | 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. |  | The duration of this study is approx 4 years | 
| Pharmacokinetics |  | 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 |  | The duration of this study is approx 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, relapsed, pharmacokinetics, antibody, safety, galiximab, efficacy, rituximab, refractory