Retreatment Study of Galiximab + Rituximab 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, 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.

Official Title
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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

Conditions
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Lymphoma, Non-Hodgkin's

Intervention / Treatment
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* Drug: galiximab in combination with rituximab


Participation Criteria
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Eligibility Criteria
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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. 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.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: galiximab in combination with rituximab|galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, galiximab, antibody, refractory, follicular, relapsed, rituximab, retreatment