A pahse 2 study of bortezomib monotherapy for Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection)

A pahse 2 study of bortezomib monotherapy for Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection) - A pahse 2 study of bortezomib monotherapy for EBV-T/NK-LPD (CAEBV)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020315

Enrollment

Registered

2015-12-24

Start date

2015-12-24

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 bortezomib monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who were diagnosed as EBV-T/NK-LPDs according to the following criteria. 1. EBV-DNA load in the peripheral blood more than 1X10e2.5 copies maicro/gDNA 2. Detection of EBV infected T of NK cells in the tissue or in the peripheral blood 3. Persistent infectious mononucleosis-like symptoms with fever, liver dysfenction and lymphadenopathy at least for 3 months. 4. Monoclonal proliferation of EBV-infected cells 1, 2 and 3 or 4 2) Age 19-69 years old 3) Performance status (ECOG) 0-2 4) Patients with sufficient hepatic, renal, cardiac, and pulmonary function 5) Patients whose written informed consents are available before registration

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 ContactAYAKO Arai

Tokyo Medical and Dental University Department of Hematology

ara.hema@tmd.ac.jp03-383-6111

Outcome results

None listed

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