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

NCT ID: NCT00363636

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2010-04-30

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 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.

Conditions

Lymphoma, Non-Hodgkin's

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

Galiximab in combination with rituximab

Intervention Type: DRUG

Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4

2

Group Type: ACTIVE_COMPARATOR

Rituximab in combination with placebo

Intervention Type: DRUG

Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4

Interventions

Galiximab in combination with rituximab

Galiximab (500mg/m2 IV) in combination with Rituximab (375 mg/m2 IV), weekly x 4

Intervention Type: DRUG

Rituximab in combination with placebo

Rituximab (375 mg/m2 IV) in combination with placebo, weekly x 4

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Other Identifiers

114-NH-301

Identifier Type: -

Identifier Source: org_study_id