UMIN-CTR Clinical Trial

Basic information
Public title	Detection of unshared-HLA restricted T lymphocytes in HLA mismatched hematopoietic stem cell transplantation
Acronym	Detection of unshared-HLA restricted T lymphocytes
Scientific Title	Detection of unshared-HLA restricted T lymphocytes in HLA mismatched hematopoietic stem cell transplantation
Scientific Title:Acronym	Detection of unshared-HLA restricted T lymphocytes
Region	Japan

Condition
Condition	Patients with hematologic disorder who undergoing HLA mismatched hematopoietic stem cell transplantation
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To detect donor-derived T lymphocytes restricted patient's HLA, which is a proof of thymic function in human adults
Basic objectives2	Others
Basic objectives -Others	N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To detect T lymphocytes restricted to patient's or donor's unique HLA
Key secondary outcomes	identification of T cell subsets of the T cells functional test of the T cells

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who received HLA mismatched hematopoietic stem cell transplantation (haploidentical, 2-HLA-haplotype-mismatched, spousal, cord blood, marrow bank)
Key exclusion criteria	N/A
Target sample size	30

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	kame@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Helth and Labour Science Research Grants for Clinical Cancer Research from the Ministry of Health, Labour and Welfare, Japan, Grants-in aid for Scientific Research (21K08408)
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	IRB, Hyogo College of Medicine
Address	1-1 Mukogawa-cho, Nishinomiya City, Hyogo
Tel	+81798456886
Email	kame@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 05 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 02 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To detect patient's or donor's unique HLA-restricted T lymphocytes in patients' blood who underwent HLA mismatched hematopoietic stem cell transplantation using HLA-A*24:02 CMV-pp65341-349tetramer (Medical & Biological Laboratories, Nagoya)

Management information
Registered date	2021 Year 05 Month 02 Day
Last modified on	2021 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050354