Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide
- Conditions
- Haploidentical Hematopoietic Stem Cell Transplantation
- Interventions
- Drug: ATG-LDPTCy
- Registration Number
- NCT06041893
- Lead Sponsor
- Samsung Medical Center
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.
- A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ATG/LD-PTCy group ATG-LDPTCy Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center
- Primary Outcome Measures
Name Time Method Acute Graft-Versus-Host Disease From the date of transplantation until 365 days after transplantation Incidence of acute GVHD ≥ grade 2
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
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
- Secondary Outcome Measures
Name Time Method Rate of CMV infection From the date of transplantation until 365 days after transplantation Rate of CMV infection
Rate of Hemorrhagic Cystitis From the date of transplantation until 365 days after transplantation Rate of Hemorrhagic Cystitis
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of