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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG-LDPTCy | Drug | antithymocyte globulin with low dose post-transplant cyclophosphamide |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immune reconstitution | 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Young Ju | Contact | 82-02-3410-0865 | hyju320@gmail.com | |
| Min Suk Rheu | Contact | 82-02-3410-3607 | minsuk.rheu@sbri.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Keon Hee Yoo, Professor | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
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To confirm the recovery of immune function, T (including Treg, Tmemory), B, and NK cell counts will be checked before hematopoietic stem cell transplantation and 1, 3, 6, and 12 months after transplantation.
| From the date of transplantation until 365 days after transplantation |