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Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

NCT00391066 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 627

Last updated 2015-10-02

No results posted yet for this study

Summary

This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.

Conditions

Interventions

DRUG

FCR + Lumiliximab

Dose, schedule, and duration specified in the protocol

DRUG

FCR

Dose, schedule, and duration specified in 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
2006-11-30
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • India
  • Israel
  • Italy
  • Lithuania
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00391066 on ClinicalTrials.gov