UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016401 |
|---|---|
| Receipt number | 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 10:28:31 |
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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
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
tmori@a3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019049
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| Registered date | File name |
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