Trial Information

Summary: A Study of Long-Term MabThera (Rituximab) Maintenance Therapy in Patients With Advanced Follicular Lymphoma

Status: Recruiting

Protocol Number: ML18167

Sponsor: Roche Hungary Ltd.

Company Division: Pharmaceutical

Official Scientific Title: Hungarian Study of Maintenance after Rituximab Pre-treatment. A multicenter, open-label study evaluating the long-term effect of MabThera (rituximab) maintenance therapy on event-free survival in patients with advanced follicular lymphoma.

Brief Summary: This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with MabThera in patients with advanced follicular lymphoma who have had a positive response to first-line treatment with a MabThera-containing regimen . The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 150.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Follicular Lymphoma

Intervention Type: Drug

Intervention Name: rituximab[MabThera/Rituxan]

Primary Outcome: 1. Event-free survival (time to progression, relapse, death, or institution of a new treatment).

Key Secondary Outcomes: 1. AEs and laboratory assessments

Inclusion Criteria:

  • adult patients >18 years of age;
  • histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment;
  • no previous anti-lymphoma treatment before induction chemotherapy (first-line-treated patients only are eligible);
  • verified complete or partial remission after first-line induction therapy including MabThera.

Exclusion Criteria:

  • Grade 3b follicular lymphoma;
  • transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma;
  • central nervous system lymphoma;
  • acquired immunodeficiency syndrome-related lymphoma;
  • other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the patient has not been disease-free for >=5 years.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2005

Trial Registration Date: 03/10/2006

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

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

  

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Trial listings updated: July 21, 2008 at 3:18:29 PM


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