Trial Information

Summary: A Study to Evaluate MabThera (Rituximab) in Patients Previously Treated for Chronic Lymphocytic Leukemia

Status: No longer recruiting

Protocol Number: BO17072

Sponsor: F. Hoffmann-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study comparing the effect of MabThera, with and without fludarabine/ cyclophosphamide, on progression-free survival and safety in patients with previously treated B-cell chronic lymphocytic leukemia

Brief Summary: This study will assess the efficacy and safety of adding MabThera to chemotherapy in patients with previously treated B-cell chronic lymphocytic leukemia (B-CLL) . The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals. Target sample size is 550.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Lymphocytic Leukemia, Chronic

Intervention Type: Drug

Intervention Name: rituximab[MabThera/Rituxan]

Primary Outcome: 1. Efficacy: Progression-free survival.

Key Secondary Outcomes: 1. Efficacy: Event free survival; disease-free survival; response duration; response rate; overall survival; proportion of patients with molecular remission. Safety: Adverse events and clinical laboratory safety tests

Inclusion Criteria:

  • adult patients >=18 years of age;
  • CD20-positive B-cell chronic lymphocytic leukemia;
  • previous treatment for CLL;
  • women of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.

Exclusion Criteria:

  • previous treatment with interferon, MabThera, or another monoclonal antibody;
  • previous bone marrow transplant;
  • a history of other malignancies within 2 years prior to study entry;
  • transformation to aggressive B-cell malignancy;
  • fertile men, and women of childbearing potential, not using adequate contraception throughout the study.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2003

Trial Registration Date: 06/24/2005

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Lille, France, 59037
Telephone: 973-235-5000 or 800-526-6367

  

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: July 21, 2008 at 2:35:45 PM


Back to Centerwatch Trial Listing by Location


Additional resources
in this illness area

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA