Trial Information

Summary: A Study of MabThera (Rituximab) Plus Sequential High-Dose Chemotherapy in Patients Newly Diagnosed With Mantle Cell Lymphoma

Status: Completed

Protocol Number: M39048

Sponsor: Roche S.p.a.

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of MabThera plus high-dose sequential chemotherapy on durable clinical response in patients newly diagnosed with mantle cell lymphoma

Brief Summary: This study will evaluate the efficacy and safety of MabThera plus high-dose sequential chemotherapy in patients with a new diagnosis of mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 91.

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:

Condition: Mantle Cell Lymphoma

Intervention Type: Drug

Intervention Name: rituximab[MabThera/Rituxan]

Primary Outcome: 1. Rate of durable complete clinical response, defined as >=24 months of relapse-free survival

Key Secondary Outcomes: 1. Rate of molecular response at treatment end and study end in patients with clinical complete remission; rate of complete response, partial response, stable disease, and progressive disease at treatment end and study end. AEs and laboratory parameters

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 60 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 10/27/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:18:29 PM