Trial Information

Summary: A Study of MabThera (Rituximab) for Treatment of Mantle Cell Non-Hodgkin's Lymphoma After Bone Marrow or Blood Stem Cell Transplantation

Status: Completed

Protocol Number: M39044

Sponsor: Roche Products Pty Limited

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the tolerability of MabThera after autologous marrow or peripheral blood stem cell transplantation in patients with mantle cell non-Hodgkin's lymphoma

Brief Summary: This study will evaluate the efficacy, safety and tolerability of MabThera in patients with mantle cell lymphoma who have received high dose chemotherapy followed by autologous bone marrow or peripheral blood stem cell transplantation. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 12.

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. Progression-free survival after treatment, efficacy of B-cell depletion, immunologic recovery, median survival at follow-up, and molecular status by polymerase chain reaction assay

Key Secondary Outcomes: 1. Adverse events; laboratory tests, vital signs, Karnofsky index, and number of infections

Inclusion Criteria:

  • adult patients 18-65 years of age;
  • confirmed mantle cell non-Hodgkin's lymphoma;
  • newly diagnosed or relapsed disease;
  • prior high-dose chemotherapy followed by autologous bone marrow or peripheral blood stem cell transplantation.

Exclusion Criteria:

  • previous organ transplant;
  • positive test result for human immunodeficiency virus (HIV) infection;
  • positive test result for hepatitis B or C virus infection;
  • concurrent disease which would exclude the administration of therapy as outlined by the study protocol.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/29/2005

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Perth, Australia, 6000
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 7, 2008 at 2:31:21 PM


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