UMIN-CTR Clinical Trial

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