A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.
- Conditions
- Diffuse large B-cell lymphoma
- Registration Number
- JPRN-UMIN000013540
- Lead Sponsor
- Department of Hematology and Oncology, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1. Primary CNS lymphoma (include intraocular lymphoma) or lymphoma with cns involvement on CT and/or MRI, or CSF examination on admission 2. Intravascular lymphoma, primary effusion lymphoma, mediastinal large B-cell lymphoma 3. Primary testicular lymphoma 4. Patients with peripheral bood involvement of lymphoma on admission 5. Prior treatment for lymphoma except lymph node biopsy and local radiation therapy 6. Presence of fluid in the third space (e.g. pleural effusions) 7. Patients with pre-existing renal insufficiency 8. Patients with another active malignancy 9. Patients with serious complications (malignant hypertension, congestive heart failure, coronary insufficiency, a new onset of myocardial infarction within 3 months, uncontrolled hyperglycemia, pulmonary fibrosis, interstitial pneumonia, etc) 10. Severe psychosis 11. Presence of uncontrollable active infection 12. Patients with allergy to drug used for conditioning regimen 13. Positive for HIV antibody, HCV antibody or HTLV-1 antibody 14. HBs antigen positive patients judged unfeasible to participate in this protocol in spite of the administration of antiviral drugs 15. Patients who are pregnant or lactating 16. Without any written consent from patients 17. Inadequate patients to enroll judged by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method