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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043973
Receipt No. R000050227
Scientific Title 2-HLA-haplotype-mismatched hematopietic stem cell transplantation
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/19

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Basic information
Public title Allogeneic hematopoietic stem cell transplantation from a two HLA-haplotype-mismatched family donor for post-transplant relapse/rejection: A prospective phase II study with statistical validation for survival benefit
Acronym HLA fully mismatched HSCT
Scientific Title 2-HLA-haplotype-mismatched hematopietic stem cell transplantation
Scientific Title:Acronym 2-HLA-haplotype-mismatched HSCT
Region
Japan

Condition
Condition hematologic malignancies relapsing or with rejection after allogeneic hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of 2-HLA-haplotype-mismatched hematopoietic stem cell transplantation with statistical validation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival at 2 years
Key secondary outcomes Safety
1) rate of engraftment at day 35
2) acute GVHD within day 100
3) complications (infections, TMA, etc)
4) other AE
5) non-relapse mortality
efficacy
6) relapse rate
7) disease-free survival

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
Other
Interventions/Control_1 Allogeneic hematopoietic stem cell transplantation from a two HLA-haplotype-mismatched family donor
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
5 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) age 15-65 years old
2) relapse or rejection case after allogeneic HSCT
3) hematologic malignancies mainly acute type leukemia
4) 2-HLA-haplotype-mismatach between patient and donor
Key exclusion criteria 1) serum Cre >2.0 mg/dl
2) serum T-Bil >2.0 mg/dl
3) selum AST and/or ALT >200 U/L
4) EF <45%
5) SpO2 <95% (room air)
6) PS (ECOG score) 3-4
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Ikegame
Organization Hyogo College of Medicine
Division name Hematology
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo
TEL +81798456886
Email kame@hyo-med.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Ikegame
Organization Hyogo College of Medicine
Division name Hematology
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo
TEL +81798456886
Homepage URL
Email haplo@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization partially supplied by Hyogo College of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization IRB, Hyogo College of Medicine
Address 1-1, Mukogawa-cho, Nishinomiya city, Hyogo, Japan
Tel +81798456066
Email rinri@hyo-med.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
2021 Year 05 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2031 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 19 Day
Last modified on
2021 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050227

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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