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

December 2, 2024 updated by: KeonHee Yoo, Samsung Medical Center

Haploidentical Hematopoietic Stem Cell Transplantation With Early Antithymocyte Globulin 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ATG/LD-PTCy group
Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center
Drug: ATG-LDPTCy
antithymocyte globulin with low dose post-transplant cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
median time to neutrophil engraftment
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
Incidence of acute GVHD ≥ grade 2
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
Incidence of moderate to severe chronic GVHD
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

Outcome Measure
Measure Description
Time Frame
Rate of CMV infection
Time Frame: From the date of transplantation until 365 days after transplantation
Rate of CMV infection
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
Rate of Hemorrhagic Cystitis
From the date of transplantation until 365 days after transplantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the date of transplantation until 365 days after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Keon Hee Yoo, Professor, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Estimated)

July 5, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMC 2023-03-094-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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