UMIN-CTR Clinical Trial

Basic information
Public title	A pahse 2 study of bortezomib monotherapy for Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection)
Acronym	A pahse 2 study of bortezomib monotherapy for EBV-T/NK-LPD (CAEBV)
Scientific Title	A pahse 2 study of bortezomib monotherapy for Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection)
Scientific Title:Acronym	A pahse 2 study of bortezomib monotherapy for EBV-T/NK-LPD (CAEBV)
Region	Japan

Condition
Condition	Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish a more effective therapy for Epstein-Barr virus positive T or NK cell lymphoproliferative disease (Chronic active Epstein-Barr virus infection), we plan and perform a study of bortezomib monotherapy investigating its safety and efficacy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Decrease rate of EBV-DNA titer in peripheral blood (whole blood)
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One cycle of bortezomib monotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	10

Research contact person
Name of lead principal investigator	1st name AYAKO Middle name Last name ARAI
Organization	Tokyo Medical and Dental University
Division name	Department of Hematology
Zip code	1138519
Address	Tokyo
TEL	+81358035211
Email	ara.hema@tmd.ac.jp

Public contact
Name of contact person	1st name AYAKO Middle name Last name Arai
Organization	Tokyo Medical and Dental University
Division name	Department of Hematology
Zip code	113-8519
Address	1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL	03-383-6111
Homepage URL
Email	ara.hema@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku
Tel	03-3813-6111
Email	ara.hema@tmd.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科歯科大学

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Due to a low number of participants.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date	2015 Year 12 Month 24 Day
Last follow-up date	2018 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 12 Month 22 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023019