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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020315
Receipt No. R000023019
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)
Date of disclosure of the study information 2015/12/24
Last modified on 2019/12/25

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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/ctr_e/ctr_view.cgi?recptno=R000023019

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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