Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 14 to 65

Individualized ATG dosing for stem cell transplantation

Official title: Application of Thymoglobulin (ATG) Individualized Dosing Model in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation.

Run by Chinese PLA General Hospital · NCT06572462 · Data updated 2026-11-12

This study is testing a personalized approach to dosing a medication for adults receiving stem cell transplants to see if it can reduce complications like infections and improve recovery.

Quick facts

PhasePhase 2
Study typeInterventional
Ages14 Years to 65 Years
SexAll
Enrollment30 (estimated)
SponsorChinese PLA General Hospital
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedDecember 31, 2020
Main results expectedDecember 30, 2024
Study endsJune 30, 2025
Registry record updatedDecember 3, 2024
Trial IDNCT06572462 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 14 to 65 with malignant hematological tumors who require allogeneic hematopoietic stem cell transplantation from an HLA-matched unrelated donor.

Probably not a fit

Patients outside the age range of 14 to 65, those without HLA-matched donors, or individuals with uncontrolled infections or serious mental illness may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a personalized dosing strategy for anti-thymocyte globulin (ATG) in adult patients undergoing unrelated donor allogeneic hematopoietic stem cell transplantation. The study aims to optimize ATG exposure to minimize complications such as cytomegalovirus reactivation and graft-versus-host disease. By monitoring ATG concentrations and adjusting doses accordingly, the trial seeks to improve patient outcomes and reduce the risks associated with standard dosing. The primary endpoint is the incidence of CMV reactivation at 180 days post-transplant.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of infections and improve overall survival rates for patients undergoing stem cell transplantation.

How similar studies have gone: Previous studies have shown promising results with individualized ATG dosing strategies in haploidentical transplants, suggesting potential success in this unrelated donor context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients with malignant hematological tumors who have indications for allogeneic hematopoietic stem cell transplantation.
2. HLA-matched unrelated donor
3. Patient age ≥14 years old and ≤65 years old
4. ALT and AST ≤ 2.5 times the upper limit of normal values, bilirubin ≤ 2 times the upper limit of normal values
5. Creatinine ≤ high limit of normal value
6. No uncontrollable infection or serious mental illness
7. Physical strength score is 0-2 (ECOG)
8. Sign the informed consent form

Exclusion Criteria:

1. Unrelated donor who is not HLA matched
2. No indication for allogeneic hematopoietic stem cell transplantation
3. Patient age \<14 years old or \>65 years old
4. The donor or recipient are pregnant
5. Suffering from mental illness or other conditions and being unable to proceed as planned

Where it's running

  • Department of Hematology, First Medical Center of Chinese PLA General Hospital
    Beijing, China
    Recruiting

Study contacts

  • Principal investigator: diahong Liu, MD — The First Medical Center of Chinese PLA General Hospital
  • Study coordinator: Sheng Chen, master
  • Email: csto301@163.com
  • Phone: 15101156205

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.