Trial Information

Summary: A Study of MabThera (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma

Status: No longer recruiting

Protocol Number: ML16865

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of MabThera alone and in combination with Roferon-A on time to treatment failure in patients with follicular or other low-grade lymphoma

Brief Summary: This study will compare the efficacy and safety of MabThera alone, and in combination with interferon-alfa 2a (Roferon-A) in patients with follicular or other CD20+ low-grade lymphoma. . Patients who have a response will receive an additional cycle of treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 313.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Lymphomas

Intervention Type: Drug

Intervention Name: rituximab[MabThera/Rituxan]

Primary Outcome: 1. Efficacy: Time to treatment failure

Key Secondary Outcomes: 1. Efficacy: Clinical objective response rate, response duration, time to progression, overall survival, molecular response Safety: Adverse events, laboratory parameters

Inclusion Criteria:

  • adult patients >18 years of age;
  • CD20+ low-grade (indolent) lymphoma of follicular and marginal zone type, small lymphocytic lymphoma without a B-CLL phenotype, or indolent lymphoma not otherwise specified;
  • stage II (with bulky disease), III, or IV lymphoma;
  • no previous chemotherapy or a maximum of 6 months chlorambucil or cyclophosphamide;
  • indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or decreased hemoglobin or platelets due to lymphoma, general symptoms (weight loss, night sweats or fever).

Exclusion Criteria:

  • prior treatment with rituximab or an interferon;
  • B-CLL, mantle cell lymphoma, lymphoplasmacytic lymphoma (Waldenstroem's disease), or central nervous system lymphoma;
  • prior malignancies, except non-melanoma skin tumors, in situ cervical cancer, or curative surgery >5 years ago;
  • positive test result for human immunodeficiency virus;
  • uncontrolled asthma or allergy requiring corticosteroids.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2002

Trial Registration Date: 09/26/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Tromsų, Norway, 9038
Telephone: 973-235-5000 or 800-526-6367

  

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: October 6, 2008 at 2:39:55 PM


Back to Centerwatch Trial Listing by Location


Additional resources
in this illness area

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA