Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06041893

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Haploidentical Hematopoietic Stem Cell Transplantation

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATG-LDPTCy

Drug

antithymocyte globulin with low dose post-transplant cyclophosphamide

Primary outcomes

  1. Emgraftment Rate

    Time frame: From the date of transplantation until 28 days after transplantation

    cumulative incidence of donor-dominant engraftment by day 28 (by case)

  2. Time to Engraftment

    Time frame: From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays

    median time to neutrophil engraftment

  3. Acute Graft-Versus-Host Disease

    Time frame: From the date of transplantation until 365 days after transplantation

    Incidence of acute GVHD ≥ grade 2

  4. 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

    Incidence of moderate to severe chronic GVHD

Secondary outcomes

  1. Rate of CMV infection

    Time frame: From the date of transplantation until 365 days after transplantation

    Rate of CMV infection

  2. Rate of Hemorrhagic Cystitis

    Time frame: From the date of transplantation until 365 days after transplantation

    Rate of Hemorrhagic Cystitis

Other outcomes

  1. Immune reconstitution

    Time frame: From the date of transplantation until 365 days after transplantation

    B cell, T cell (CD3+, CD4+, CD8+, Regulatory, Memory) NK cell count (of peripheral blood) at 1, 3, 6, 12 months post-transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Hee Young Ju

CONTACT

[email protected]

82-02-3410-0865

Min Suk Rheu

CONTACT

[email protected]

82-02-3410-3607

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.