A pilot study of L-asparaginase monotherapy for Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection)

A pilot study of L-asparaginase monotherapy for Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection) - A pilot study of L-asparaginase monotherapy for EBV-T/NK-LPD (CAEBV)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003498

Enrollment

Registered

2010-04-16

Start date

2010-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection)

Interventions

One cycle of L-asparaginase monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients of Epstein-Barr virus positive T or NK cell lymphoproliferative disease, diagnosed according to the following: 1) EBV-DNA titer in peripheral whole blood >= 1x10E2.5 copy/ugDNA 2) Detection of EBV infected T cell or NK cell in the tissue or peripheral blood 3) Persistent infectious mononucleosis- like symptoms with fever, liver dysfunction and lymphadenopathy for 3 at least months 4) Monoclonal proliferation of EBV- infected cells 1,2 and 3 or 4 (2)Age 14-69 years (3)Performance status (ECOG) 0-2 (4)Patients with sufficient hepatic, renal, cardiac, and pulmonary function (5)A patient whose written informed consent is gettable before registration (when a patient is a minor, patient's and parent's written informed consent should be obtained.)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Decrease rate of EBV-DNA titer in peripheral blood (whole blood)	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactMinako Jinta

Tokyo Medical and Dental University Department of Hematology

ara.hema@tmd.ac.jp03-3813-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026