Trial Information

Summary: A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.

Status: Recruiting

Protocol Number: ML19652

Sponsor:

Company Division: Pharmaceutical

Official Scientific Title: An open label study of the effect of Rituxan, high dose methotrexate and high dose cytarabine on response rate in patients with primary central nervous system lymphoma.

Brief Summary: This single arm study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 i.v.) plus methotrexate (8g/m2) given at intervals up to week 22, plus cytarabine (2g/m2 i.v.) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Lymphomas

Intervention Type: Drug

Intervention Name: rituximab [MabThera/Rituxan]

Primary Outcome: Complete response rate; overall response rate. Timeframe: Event driven.

Key Secondary Outcomes:

Relapse rate, overall survival, progression-free survival. Timeframe: Event driven.
AEs, laboratory parameters. Timeframe: Throughout study.

Inclusion Criteria:

  • adult patients, 18-80 years of age;
  • histological diagnosis of primary central nervous system lymphoma;
  • B-cell proliferation verified by positive staining for CD20;
  • ≥1 measurable lesion.

Exclusion Criteria:

  • prior chemotherapy, other than corticosteroids, ≥6 weeks before and after diagnosis or surgery;
  • history of prior cranial irradiation;
  • evidence of plurisystemic non-Hodgkin's lymphoma;
  • other active malignant disease (other than basal cell or squamous cell cancer of skin, or cancer in situ of cervix;
  • uncontrolled active infection.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2007

Trial Registration Date: 08/08/2007

Date Last Updated: 04/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Greenfield Park, QC, Canada, J4V 2H1
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 3:19:35 PM


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