Individualized ATG dosing for stem cell transplantation

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

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

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06572462 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

Eligibility 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 this trial is running

Beijing

• Department of Hematology, First Medical Center of Chinese PLA General Hospital — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: diahong Liu, MD — First Medical Center of Chinese PLA General Hospital
• Study coordinator: Sheng Chen, master

Conditions: Cytomegalovirus Infections, Infection Reactivation, Stem Cell Transplant Complications