UMIN-CTR Clinical Trial

Basic information
Public title	In-house platelet transfusion from a corresponding HLA donor to an anti-HLA-antibody-positive patient
Acronym	In-house platelet transfusion
Scientific Title	In-house platelet transfusion from a corresponding HLA donor to an anti-HLA-antibody-positive patient
Scientific Title:Acronym	In-house platelet transfusion
Region	Japan

Condition
Condition	Hematologic disorders
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish a method of attenuation of antibody titer by in-house platelet transfusion from a corresponding HLA donor to an anti-HLA-antibody-positive patient
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Titer of donor-specific antibodies
Key secondary outcomes	engraftment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	in-house platelet transfusion
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	18 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient with hematopoietic diseases who are refractory to chemotherapy and for whom allogeneic hematopoietic stem cell transplantation is the only curative option
Key exclusion criteria	Case that sufficient stem cells cannot be harvested from the donor
Target sample size	1

Research contact person
Name of lead principal investigator	1st name Ayako Middle name Last name Arai
Organization	St. Marianna University School of Medicine
Division name	St. Marianna University School of Medicine
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL	044-977-8111
Email	ara.hema@marianna-u.ac.jp

Public contact
Name of contact person	1st name Ayako Middle name Last name Arai
Organization	St. Marianna University School of Medicine
Division name	Division of Hematology & Oncology, Department of Internal Medicine
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL	044-977-8111
Homepage URL
Email	ara.hema@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School 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	Ethics review board, St. Marianna University School of Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japa
Tel	044-977-8111
Email	k-sienbu.mail@marianna-u.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	聖マリアンナ医科大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2022 Year 12 Month 08 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	Enrolling by invitation
Date of protocol fixation	2022 Year 11 Month 24 Day
Date of IRB	2022 Year 11 Month 29 Day
Anticipated trial start date	2022 Year 12 Month 08 Day
Last follow-up date	2023 Year 12 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 12 Month 07 Day
Last modified on	2022 Year 12 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056629