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

Biogen

Status and phase

Terminated

Phase 3

Conditions

Lymphoma, Non-Hodgkin's

Treatments

Drug: Rituximab in combination with placebo

Drug: Galiximab in combination with rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00363636

114-NH-301

Details and patient eligibility

About

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.

Enrollment

340 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.