Haploidentical Hematopoietic Stem Cell Transplantation
Conditions
Keywords
post transplant cyclophosphamide, antithymocyte globulin
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.
Interventions
DRUGATG-LDPTCy
antithymocyte globulin with low dose post-transplant cyclophosphamide
Sponsors
Samsung Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Acute Graft-Versus-Host Disease | From the date of transplantation until 365 days after transplantation | Incidence of acute GVHD ≥ grade 2 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune reconstitution | 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 |
Countries
South Korea
Contacts
Primary ContactHee Young Ju
Backup ContactMin Suk Rheu
Outcome results
None listed