Trial Information

Summary: A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

Status: Recruiting

Protocol Number: ML20493

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of the addition of MabThera to standard chemotherapy on clinical response in patients with previously untreated mantle cell lymphoma

Brief Summary: This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 50.

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: Mantle Cell Lymphoma

Intervention Type: Drug

Intervention Name: rituximab [MabThera/Rituxan]

Primary Outcome: 1. Complete and partial response Time frame: Event driven

Key Secondary Outcomes: 1. Event-free survival, progression-free survival, time to treatment failure. Time frame: AEs, laboratory parameters.

Inclusion Criteria:

  • histologically-proven mantle cell lymphoma;
  • previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria:

  • known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
  • active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
  • serious disorders interfering with full standard dosing chemotherapy;
  • stage I disease.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: June, 2007

Trial Registration Date: 04/17/2007

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Gyor, Hungary, 9002
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 7, 2008 at 2:40:23 PM


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