Ireland
--:--IST
Recruiting Observational

Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide

NCT06041893 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2023-05-29
Last updated
2024-12-03

Condition(s) studied

Haploidentical Hematopoietic Stem Cell Transplantation

Investigational drug(s) / intervention(s)

ATG-LDPTCy

ATG-LDPTCy: antithymocyte globulin with low dose post-transplant cyclophosphamide

Study summary

Aim of this study is to investigate the effect of early administration of anti-thymocyte globulin and post-transplant low-dose cyclophosphamide in heploidentical hematopoietic stem cell transplantation.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center. Exclusion Criteria: * A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.

Primary outcome measure(s)

  • Emgraftment Rate — From the date of transplantation until 28 days after transplantation
    cumulative incidence of donor-dominant engraftment by day 28 (by case)
  • Time to Engraftment — From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays
    median time to neutrophil engraftment
  • Acute Graft-Versus-Host Disease — From the date of transplantation until 365 days after transplantation
    Incidence of acute GVHD ≥ grade 2
  • Chronic Graft-Versus-Host Disease — From the date of transplantation until the date of documentation of highest level of chronic GVHD, assessed up to 2 years after transplantation
    Incidence of moderate to severe chronic GVHD

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06041893 on ClinicalTrials.gov ↗ ← All trials in South Korea