UMIN-CTR Clinical Trial

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

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

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科歯科大学

Date of disclosure of the study information

2015

Year

12

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

12

Month

22

Day

Last modified on

2019

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023019