Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

NCT00801060 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-10-02

No results posted yet for this study

Summary

This is a Phase 2, randomized, open-label, multicenter study in subjects with previously untreated CLL. It is designed to evaluate safety and efficacy of fludarabine, cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.

Conditions

Interventions

DRUG

Lumiliximab + FCR

Dose, schedule, and duration in the protocol

DRUG

FCR

Dosage, schedule, and duration in the protocol

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00801060 on ClinicalTrials.gov