Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061499) titled 'Depletion of Anti-HLA Antibodies by Targeted HLA-Expressing Platelet Transfusion' on June 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Aichi Medical University

Condition: Condition - Hematologic diseases requiring allogeneic hematopoietic cell transplantation Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 10

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070369

Disclaimer: Curated by HT Syndication.