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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517699
First received: August 16, 2007
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

This 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 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Lymphoma
Drug: rituximab [MabThera/Rituxan]
Drug: Methotrexate
Drug: Cytarabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Complete response rate;overall response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse rate; overall survival;PFS [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
750mg/m2 iv
Drug: Methotrexate
8g/m2 iv
Drug: Cytarabine
2g/m2 iv

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517699

Locations
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Quebec City, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517699     History of Changes
Other Study ID Numbers: ML19652
Study First Received: August 16, 2007
Last Updated: October 7, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Methotrexate
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014