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
- 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
- Bidimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single
- 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.