Status:
TERMINATED
A Study of Galiximab + Rituximab Versus Rituximab + Placebo in Follicular Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Biogen
Conditions:
Lymphoma, Non-Hodgkin's
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Key
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00363636
Start Date
September 1 2006
End Date
April 1 2010
Last Update
October 2 2015
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