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

NCT00363636 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2015-10-02

No results posted yet for this study

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

Interventions

DRUG

Galiximab in combination with rituximab

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

DRUG

Rituximab in combination with placebo

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-01-31
Completion
2010-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00363636 on ClinicalTrials.gov