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:
Creteil, France, 94010
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:36:17 PM


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