Trial Information

Summary: MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

Status: No longer recruiting

Protocol Number: MO19872

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A study to evaluate the safety of MabThera (rituximab) maintenance therapy in patients with follicular non-Hodgkin's lymphoma who have responded to induction therapy.

Brief Summary: This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. Target sample size is 500.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Non-Hodgkin's Lymphoma

Intervention Type: Drug

Intervention Name: rituximab [MabThera/Rituxan]

Primary Outcome: 1. Incidence of all, and of grade 3/4, adverse events. Time frame: Throughout study

Key Secondary Outcomes: 1. PFS, event free survival, overall survival, time to next lymphoma treatment, PR to CR conversion rate. Time frame: Event driven

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
  • patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
  • demonstrated partial or complete response to induction therapy.

Exclusion Criteria:

  • stable or progressive disease after most recent induction therapy;
  • transformation to high grade lymphoma;
  • patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2006

Trial Registration Date: 07/19/2006

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
La Plata, Argentina, 1900
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 7, 2008 at 2:33:48 PM


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