A pilot study of L-asparaginase monotherapy for Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection)
Not Applicable
- Conditions
- Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection)
- Registration Number
- JPRN-UMIN000003498
- Lead Sponsor
- Tokyo Medical and Dental University School of Medicine, Department of Hematology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Need for radiation more than 15 Gy including palliation at the time of registration (2)Uncontrollable hypertension (3)History of myocardial infarction or angina or cardiomyopathy (4)HBs antigen positive (5)Severe infection except EBV (6)Liver cirrhosis, either biopsy proven or clinically diagnose (7)Active double cancer: overlapping cancer or asynchronous cancer within 5 years. Carcinoma in situ, intramucosal cancers, and other equivalent lesions are not included for the active double cancer. (8)Women during pregnancy, lactation period or of childbearing potentials not using a reliable contraceptive method (9)Use of major tranquilizer, antidepressant, or antimanic (10)Severe psychosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease rate of EBV-DNA titer in peripheral blood (whole blood)
- Secondary Outcome Measures
Name Time Method Overall response rate; ORR (rate of complete response (CR) or partial response (PR)), the rate of adverse events, and decrease rate of EBV-DNA titer in peripheral blood (plasma)