Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: Keon Hee Yoo, Professor, Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMC 2023-03-094-002