Trial Information

Summary: 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 a placebo) in follicular NHL. Safety and pharmacokinetics (PK) will also be evaluated.

A study of Galiximab and Rituximab versus Rituximab plus Placebo for the Treatment of Subjects With Relapsed or Refractory, Follicular Non-Hodgkin’s Lymphoma (NHL).

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

If you would like to learn more about participating in this study, please send an e-mail message using the form below.