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

NCT06041893 | Recruiting

• 1 other identifier: SMC 2023-03-094-002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Haploidentical Hematopoietic Stem Cell Transplantation

Keywords

post transplant cyclophosphamide; antithymocyte globulin

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• Rate of CMV infection

  From the date of transplantation until 365 days after transplantation

• Rate of Hemorrhagic Cystitis

  From the date of transplantation until 365 days after transplantation

Other Outcomes (1)

• Immune reconstitution

  From the date of transplantation until 365 days after transplantation

Study Arms (1)

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

Interventions

ATG-LDPTCy DRUG

antithymocyte globulin with low dose post-transplant cyclophosphamide

ATG/LD-PTCy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center

You may qualify if:

• Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.

You may not qualify if:

• A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

Study Officials

• Keon Hee Yoo, Professor

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Young Ju

CONTACT

82-02-3410-0865; hyju320@gmail.com

Min Suk Rheu

CONTACT

82-02-3410-3607; minsuk.rheu@sbri.co.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: September 18, 2023
• Study Start: May 29, 2023
• Primary Completion: July 5, 2025
• Study Completion: December 31, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

KR (1)