Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.
Disqualifiers
A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.
Trial 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
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
ATG-LDPTCy
Drugantithymocyte globulin with low dose post-transplant cyclophosphamide
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: ATG/LD-PTCy group1 intervention
Trial outcomes
Primary outcomes
1
Emgraftment Rate
cumulative incidence of donor-dominant engraftment by day 28 (by case)
Time frame
From the date of transplantation until 28 days after transplantation2
Time to Engraftment
median time to neutrophil engraftment
Time frame
From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays3
Acute Graft-Versus-Host Disease
Incidence of acute GVHD ≥ grade 2
Time frame
From the date of transplantation until 365 days after transplantation4
Chronic Graft-Versus-Host Disease
Incidence of moderate to severe chronic GVHD
Time frame
From the date of transplantation until the date of documentation of highest level of chronic GVHD, assessed up to 2 years after transplantationSecondary outcomes
1
Rate of CMV infection
Rate of CMV infection
Time frame
From the date of transplantation until 365 days after transplantation2
Rate of Hemorrhagic Cystitis
Rate of Hemorrhagic Cystitis
Time frame
From the date of transplantation until 365 days after transplantationOther outcomes
1
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
Time frame
From the date of transplantation until 365 days after transplantationSponsors and contacts
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Source ClinicalTrials.gov