UMIN-CTR Clinical Trial

Public title

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

Acronym

A pilot study of L-asparaginase monotherapy for EBV-T/NK-LPD (CAEBV)

Scientific Title

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

Scientific Title:Acronym

A pilot study of L-asparaginase 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 L-asparaginase monotherapy investigating its safety and efficacy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

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

Uncontrolled

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 L-asparaginase 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

14

years-old

<=

Age-upper limit

69

years-old

>=

Gender

Male and Female

Key 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.)

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

5

Name of lead principal investigator

1st name
Middle name
Last name	Ayako Arai

Organization

Tokyo Medical and Dental University

Division name

Department of Hematology

Zip code

Address

1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Minako Jinta

Organization

Tokyo Medical and Dental University

Division name

Department of Hematology

Zip code

Address

TEL

03-3813-6111

Homepage URL

Email

ara.hema@tmd.ac.jp

Institute

Tokyo Medical and Dental University School of Medicine, Department of Hematology

Institute

Department

Personal name

Organization

Ministry of health, labor and welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

04

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

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

Completed

Date of protocol fixation

2010

Year

02

Month

03

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

04

Month

16

Day

Last modified on

2011

Year

02

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004234