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Recruiting NCT06041893

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

— Observational Haploidentical Hematopoietic Stem Cell Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ATG-LDPTCy.
Who it may be relevant to
Registry conditions: Haploidentical Hematopoietic Stem Cell Transplantation. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Hematopoietic stem cell transplantation from a haploidentical donor (haplo-HCT) are increasingly used in patients lacking a matched donor, but the optimal strategy needs to be defined. This study aims to investigate the outcome of haplo-HCT with early antithymocyte globulin and low dose posttransplant cyclophosphamide (ATG/LD-PTCy) in a single center.

Interventions

  • Drug ATG-LDPTCy
    antithymocyte globulin with low dose post-transplant cyclophosphamide

Primary outcome measures

  • Emgraftment Rate [Time frame: From the date of transplantation until 28 days after transplantation]
  • Time to Engraftment [Time frame: From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays]
  • Acute Graft-Versus-Host Disease [Time frame: From the date of transplantation until 365 days after transplantation]
  • Chronic Graft-Versus-Host Disease [Time frame: From the date of transplantation until the date of documentation of highest level of chronic GVHD, assessed up to 2 years after transplantation]
Secondary outcome measures (2)
  • Rate of CMV infection [Time frame: From the date of transplantation until 365 days after transplantation]
  • Rate of Hemorrhagic Cystitis [Time frame: From the date of transplantation until 365 days after transplantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT06041893 · SMC 2023-03-094-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗