UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061499 |
|---|---|
| Receipt number | R000070369 |
| Scientific Title | Depletion of Anti-HLA Antibodies by Targeted HLA-Expressing Platelet Transfusion |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/08 20:14:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Depletion of Anti-HLA Antibodies by Targeted HLA-Expressing Platelet Transfusion
Acronym
Depletion of Anti-HLA Antibodies by HLA-Expressing Platelet
Scientific Title
Depletion of Anti-HLA Antibodies by Targeted HLA-Expressing Platelet Transfusion
Scientific Title:Acronym
Depletion of Anti-HLA Antibodies by Targeted HLA-Expressing Platelet Transfusion
Region
| Japan |
Condition
Condition
Hematologic diseases requiring allogeneic hematopoietic cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether transfusion of platelet products expressing target HLA antigens can adsorb and reduce circulating anti-HLA antibodies in patients with hematologic diseases who need allogeneic hematopoietic cell transplantation, thereby improving engraftment outcomes after transplantation. Furthermore, this study aims to investigate the structural characteristics and immunological background of anti-HLA antibody responses by performing detailed analyses of changes in antibody reactivity against multiple HLA antigens sharing common eplets through the combined use of eplet analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in anti-HLA antibody levels (mean fluorescence index: MFI) before and after transfusion of target HLA-expressing platelets
Key secondary outcomes
1) Identification of anti-HLA antibody recognition sites by eplet analysis
2) Engraftment rate following transfusion of target HLA-expressing platelets
3) Evaluation of complications associated with transfusion of target HLA-expressing platelets
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1. Preparation of Target HLA-Expressing Platelets
If platelet products expressing the target HLA antigens are available from the Japanese Red Cross Society, those products will be used. If such products cannot be supplied by the Japanese Red Cross Society, platelet collection will be performed from related donors, such as family members, who possess the corresponding HLA type. Eligible cooperating donors will include relatives within the fourth degree of kinship and spouses who meet eligibility criteria equivalent to those applied to hematopoietic cell transplantation donors. Platelet collection will be performed according to standard apheresis procedures approved in routine clinical practice. The target collection volume will generally be approximately 10-20 units, determined comprehensively based on the patient's anti-HLA antibody levels, body size, and clinical condition.
2. Procedures for Transfusion of Target HLA-Expressing Platelets and Hematopoietic Cell Transplantation
Collected platelet products will undergo irradiation with 17.5 Gy in the transfusion department and will subsequently be transfused to the patient over approximately 2 hours. Hematopoietic cell transplantation will then be performed after an interval of 2 hours following completion of the platelet transfusion. Both the transfusion and transplantation procedures will be conducted in accordance with standard techniques used in routine clinical practice.
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
1. Eligibility for allogeneic hematopoietic cell transplantation at our institution
2. Presence of donor-specific anti-HLA antibodies (DSA) with an MFI of >=5,000
3. Availability of target HLA-expressing platelet products
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikegame |
Organization
Aichi Medical University
Division name
Hematopoietic cell transplantation center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute City, Aichi 480-1195, Japan
TEL
+81-561-63-2086
kame@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikegame |
Organization
Aichi Medical University
Division name
Hematopoietic cell transplantation center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute City, Aichi 480-1195, Japan
TEL
+81-561-63-2086
Homepage URL
kame@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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, Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute City, Aichi 480-1195, Japan
Tel
+81-561-62-3311
aichi-med@esct.bvits.com
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
| 2026 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2032 | 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
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070369
