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

Haploidentical Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041893
• Other study ID #: SMC 2023-03-094-002
• Status: Recruiting
• Start date: May 29, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Samsung Medical Center
• Contact: Hee Young Ju
• Phone: 82-02-3410-0865
• Email: hyju320[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Haploidentical Hematopoietic Stem Cell Transplantation

Intervention

Drug:
• ATG-LDPTCy
antithymocyte globulin with low dose post-transplant cyclophosphamide

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Emgraftment Rate	cumulative incidence of donor-dominant engraftment by day 28 (by case)	From the date of transplantation until 28 days after transplantation
Primary	Time to Engraftment	median time to neutrophil engraftment	From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays
Primary	Acute Graft-Versus-Host Disease	Incidence of acute GVHD = grade 2	From the date of transplantation until 365 days after transplantation
Primary	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	Rate of CMV infection	Rate of CMV infection	From the date of transplantation until 365 days after transplantation
Secondary	Rate of Hemorrhagic Cystitis	Rate of Hemorrhagic Cystitis	From the date of transplantation until 365 days after transplantation