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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 31, 2020 |
| Main results expected | December 30, 2024 |
| Study ends | June 30, 2025 |
| Registry record updated | December 3, 2024 |
| Trial ID | NCT06572462 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.
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CMV-specific T cells after CMV reactivation in adults after HSCT
This study tests CMV-specific immune recovery in adults who have their first CMV reactivation after an allogeneic HSCT to see how CMV-specific T cells change over time.
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Biomarkers linked to congenital CMV using newborn blood spots
Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.
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T-cell–guided letermovir stopping after allogeneic stem cell transplant
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Combining ruxolitinib with corticosteroids for severe acute graft‑versus‑host disease
This trial tests whether adding ruxolitinib to corticosteroids as first‑line treatment helps people who develop severe acute graft‑versus‑host disease after a first stem cell transplant.
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Venetoclax added to reduced-intensity conditioning for combined stem cell and kidney transplant
This trial tests whether adding venetoclax to a reduced-intensity conditioning regimen is safe for adults with blood cancers who are receiving a combined stem cell and kidney transplant from a matched or partially matched donor.
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First-line ruxolitinib plus corticosteroids for grade II acute graft-versus-host disease
This trial will test whether adding ruxolitinib to standard corticosteroids helps people with new grade II acute graft-versus-host disease after an allogeneic stem cell transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.