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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Haploidentical Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Drug: ATG-LDPTCy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ATG/LD-PTCy group<br>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<br>* antithymocyte globulin with low dose post-transplant cyclophosphamide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emgraftment Rate | cumulative incidence of donor-dominant engraftment by day 28 (by case) | From the date of transplantation until 28 days after transplantation | 
| Time to Engraftment | 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 | Incidence of acute GVHD ≥ grade 2 | From the date of transplantation until 365 days after transplantation | 
| Chronic Graft-Versus-Host Disease | 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 | Rate of CMV infection | From the date of transplantation until 365 days after transplantation | 
| Rate of Hemorrhagic Cystitis | Rate of Hemorrhagic Cystitis | From the date of transplantation until 365 days after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post transplant cyclophosphamide, antithymocyte globulin