Trial Information

Summary: A Study of MabThera (Rituximab) in Combination With a Chemotherapy Regimen for the Treatment of Chronic Lymphocytic Leukemia.

Status: No longer recruiting

Protocol Number: ML17102

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

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

Brief Summary: This study will assess the efficacy and safety of adding MabThera to chemotherapy in patients with previously untreated B-cell chronic lymphocytic leukemia (B-CLL). The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Target sample size is 760.

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. Progression-free survival

Key Secondary Outcomes: 1. Event-free survival; overall survival; disease-free survival; duration of remission; time to new CLL treatment or death; rates of molecular, complete, and partial remission; treatment-related adverse events; pharmacoeconomic impact; QOL

Inclusion Criteria:

  • adult patients >=18 years of age;
  • confirmed B-CLL;
  • no previous chemotherapy, radiotherapy, or immunotherapy for the treatment of CLL;
  • women of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment, and must be prepared to use reliable contraception for the duration of treatment, and for 2 months after the end of treatment.

Exclusion Criteria:

  • women who are pregnant or lactating;
  • active secondary malignancy currently requiring treatment;
  • transformation to aggressive B-cell malignancy.

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:
Marseille, France, 13285
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:35:46 PM


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