Actively Recruiting

All Genders
ID06041893

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

Led by Samsung Medical Center · Updated on 2024-12-03

20

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients undergoing haploidentical hematopoietic stem cell transplantation (haplo-HCT) to evaluate the effects of early antithymocyte globulin and low-dose post-transplant cyclophosphamide (ATG/LD-PTCy). This observational study aims to define the best approach for patients lacking a matched donor, focusing on outcomes after this specific conditioning regimen at a single center. Participants receive haploidentical stem cell transplants with conditioning using early ATG and low-dose cyclophosphamide after transplant. The study specifically monitors patients treated at the pediatrics department of Samsung Medical Center, following a standardized treatment plan involving ATG and LD-PTCy. During the study, researchers track key outcomes such as engraftment rate and time, acute and chronic graft-versus-host disease (GVHD), and rates of complications like cytomegalovirus infection and hemorrhagic cystitis. These outcomes are measured at various time points up to two years post-transplant. Participant involvement includes careful monitoring of blood counts and clinical status, with a total follow-up period extending to two years after transplantation.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.
Not Eligible

You will not qualify if you...

  • Patients or their legal representatives who do not consent or are unable to give written consent.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From transplantation up to 28 days

Participants undergo haploidentical hematopoietic stem cell transplantation with early antithymocyte globulin and low dose post-transplant cyclophosphamide.

Regular visits during initial 28 days post-transplant

Follow-up

Duration - Up to 2 years after transplantation

Participants are monitored for acute and chronic graft-versus-host disease, cytomegalovirus infection, and other post-transplant complications.

Periodic follow-up visits over 2 years

Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea

Actively Recruiting

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Research Team

H

Hee Young Ju

M

Min Suk Rheu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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