Trial Information

Summary: CHAIROS study A Study of MabThera (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

Status: No longer recruiting

Protocol Number: ML18434

Sponsor: Roche Austria GmbH

Company Division: Pharmaceutical

Official Scientific Title: CHAIROS - Effect of early brief intensification by chemoimmunotherapy with FCR followed by FR and Rituximab maintenance on clinical response in chemo-naïve patients with B-CLL

Brief Summary: This study will evaluate the efficacy and safety of intense combination treatment including MabThera, followed by MabThera maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals. Target sample size is 40.

Study Phase: IV

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. Complete response rate.

Key Secondary Outcomes: 1. Clinical efficacy (complete and partial response) after induction and maintenance therapy; molecular complete response; hematologic and non-hematologic toxicities

Inclusion Criteria:

  • adult patients >=18 years of age;
  • B-cell CLL;
  • no previous chemotherapy, radiotherapy, or immunotherapy.

Exclusion Criteria:

  • positive Coombs test, and/or autoimmune haemolytic anemia;
  • reduced organ function, or bone marrow dysfunction not due to CLL;
  • patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
  • patients with a history of severe cardiac disease.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2005

Trial Registration Date: 03/10/2006

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Leoben, Austria, 8700
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: August 20, 2008 at 2:20:54 PM


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