Trial Information

Summary: A Study of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia (CLL)

Status: Recruiting

Protocol Number: ML18429

Sponsor: Productos Roche, SAQeI Argentina

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of MabThera plus fludarabine and cyclophosphamide on progression-free survival in patients with B-cell chronic lymphocytic leukemia

Brief Summary: This study will evaluate the efficacy and safety of MabThera in combination with chemotherapy in patients with B-cell CLL. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 15.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Lymphocytic Leukemia, Chronic

Intervention Type: Drug

Intervention Name: rituximab[MabThera/Rituxan]

Primary Outcome: 1. Progression-free survival, overall survival, and objective response

Key Secondary Outcomes: 1. Adverse events, clinical laboratory tests of safety, and vital signs

Inclusion Criteria:

  • adult patients >=18 years of age;
  • B-cell CLL;
  • no previous treatment for leukemia.

Exclusion Criteria:

  • history of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer;
  • co-morbid condition requiring long-term (>1 month) systemic corticosteroids during study treatment;
  • known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV).

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2006

Trial Registration Date: 08/29/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Córdoba, Argentina, 5016
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: August 20, 2008 at 2:21:33 PM


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