Haploidentical Hematopoietic Stem Cell TransplantationNCT06041893
Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide
An observational study of Haploidentical Hematopoietic Stem Cell Transplantation, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Haploidentical Hematopoietic Stem Cell Transplantation
- What is being tested?
- ATG-LDPTCy
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2023to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.
Who cannot join
- A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Hee Young Ju, 82-10-3410-0865, heeyoung.ju@samsung.com
About this study
Official title: Haploidentical Hematopoietic Stem Cell Transplantation With Early Antithymocyte Globulin and Low Dose Post-transplant Cyclophosphamide
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.
Read the 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.
- Being tested
- ATG-LDPTCy
- Keywords
- post transplant cyclophosphamide, antithymocyte globulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-LDPTCyDrug
antithymocyte globulin with low dose post-transplant cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ATG-LDPTCy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emgraftment Rate
cumulative incidence of donor-dominant engraftment by day 28 (by case)
Measured: From the date of transplantation until 28 days after transplantation
Time to Engraftment
median time to neutrophil engraftment
Measured: 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
Measured: From the date of transplantation until 365 days after transplantation
Chronic Graft-Versus-Host Disease
Incidence of moderate to severe chronic GVHD
Measured: 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
Rate of CMV infection
Measured: From the date of transplantation until 365 days after transplantation
Rate of Hemorrhagic Cystitis
Rate of Hemorrhagic Cystitis
Measured: From the date of transplantation until 365 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start29 May 2023
- Primary completion5 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haploidentical Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KeonHee Yoo, Samsung Medical Center
- Investigators
- Keon Hee Yoo, Professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041893
- Sponsor's protocol ID
- SMC 2023-03-094-002
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haploidentical Hematopoietic Stem Cell Transplantation With Early Antithymocyte Globulin and Low Dose Post-transplant Cyclophosphamide
- ClinicalTrials.gov ID
- NCT06041893
- Acronym / sponsor ID
- SMC 2023-03-094-002
- Keywords
- post transplant cyclophosphamide, antithymocyte globulin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATG/LD-PTCy group | – | Drug: ATG-LDPTCyPatients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.
Key exclusion criteria (1 listed)
- A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-LDPTCyantithymocyte globulin with low dose post-transplant cyclophosphamide | Drug | ATG/LD-PTCy group |
Primary outcome
Emgraftment Rate
Time frame: From the date of transplantation until 28 days after transplantation
cumulative incidence of donor-dominant engraftment by day 28 (by case)
Time to Engraftment
Time frame: 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
Time frame: From the date of transplantation until 365 days after transplantation
Incidence of acute GVHD ≥ grade 2
Chronic Graft-Versus-Host Disease
Time frame: 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
2 secondary outcomes
Rate of CMV infection
Time frame: From the date of transplantation until 365 days after transplantation
Rate of Hemorrhagic Cystitis
Time frame: From the date of transplantation until 365 days after transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keon Hee Yoo, Professor principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haploidentical Hematopoietic Stem Cell Transplantation, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hee Young Ju (82-02-3410-0865, hyju320@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emgraftment Rate (time frame: From the date of transplantation until 28 days after transplantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.