A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517699
First received: August 16, 2007
Last updated: September 16, 2009
Last verified: September 2009
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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: rituzimab [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 Completion Date: | May 2009 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rituzimab [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 More Information
No publications provided
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00517699 History of Changes |
| Other Study ID Numbers: | ML19652 |
| Study First Received: | August 16, 2007 |
| Last Updated: | September 16, 2009 |
| 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 May 19, 2013