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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016401
Receipt No. R000019049
Scientific Title Evaluation of safety and efficacy of tranilast in preventing graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2015/02/10
Last modified on 2019/08/05

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Basic information
Public title Evaluation of safety and efficacy of tranilast in preventing graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
Acronym Tranilast in preventing GVHD after allogeneic HSCT
Scientific Title Evaluation of safety and efficacy of tranilast in preventing graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Tranilast in preventing GVHD after allogeneic HSCT
Region
Japan

Condition
Condition Paients aged 20 years or greater who undergo allogeneic hematopoietic stem cell transplatation from an unrelated donor
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and efficacy of tranilastin preventing graft-versus-host disease after allogeneic hematopietic stem cell transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Non-hematological adverse events within 28 days after transplantation
Key secondary outcomes

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Administration of tranilast to hematopoietic stem cell transplant recipients
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) 20 years old or greater at consent
2) Hematologial disorder which has indication for allogeneic HSCT
3) Available unrelated donor who are donating bone marrow or PBSC, fulfilling the following criteria
(1)HLA-A,B,DR serologically and genetically matched
(2)HLA-A,B,DR serologially matched, but 1 or 2 loci genetically mismatched.
(3) HLA-A,B,DR 1 locus-mismatched, but genetically matched in other loci.
4) Any conditioning regimen applicable. In patients with 3)(3) donor, anti-thymocyte globulin can be used.
5) Tacrolimus and short-term methotrexate are used for GVHD prophylaxis.
6) ECOG PS 0 or 1.
7) No major organ dysfunction
(1) SaO2 94% or greater
(2) Serum Cr 1.5 mg/dl or less
(3) Serum T. Bil 2.0 mg/dl or less
(4) AST and ALT x3 institutional upper limit or less
(5) Without abnormalities in electrocardiogram requiring treatment
(6) Ultracardiography ejection fraction 55% or greater
Key exclusion criteria 1) Poorly controlled diabetes even with insulin treatment
2) Poorly controlled hypertension
3) Poorly controlled active infection
4) Not expecting 3 months or longer survival due to refractory disease or infection
5) Requring immediate tapering of immunosuppressant because of high risk of disease replapse
6) Active disease infiltration of central nervous system
7) Active double cancer
8) Pregnant or nursing patients
9) Poorly controlled psychiatric disorder
10) History of hypersensitivity or moderate or greater adverse events due to tranilast, cyclosporine, tacrolimus, and methotrexate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name TAKEHIKO
Middle name
Last name MORI
Organization Keio University School of Medicine
Division name Division of Hematology
Zip code 1608582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email tmori@a3.keio.jp

Public contact
Name of contact person
1st name Takehiko
Middle name
Last name MORI
Organization Keio University School of Medicine
Division name Division of Hematology
Zip code 1608582
Address 35Shinanomachi, Shinjuku-ku,
TEL 0333531211
Homepage URL
Email tmori@a3.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethical Committe of Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 10 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
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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 01 Month 30 Day
Date of IRB
2015 Year 01 Month 26 Day
Anticipated trial start date
2015 Year 02 Month 10 Day
Last follow-up date
2018 Year 12 Month 30 Day
Date of closure to data entry
2019 Year 01 Month 30 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 31 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019049

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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