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NCT06572462
ATG Individualized Dosing Model in URD-PBSCT.
Phase 2 trial testing individualized ATG dosing strategy in Cytomegalovirus Infections in 30 participants. Currently enrolling.
30 December 2024
Quick facts
| Lead sponsor | Chinese PLA General Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 31 December 2020 |
| Primary completion | 30 December 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- individualized ATG dosing strategy — full drug profile →
Conditions studied
- Cytomegalovirus Infections — all drugs for Cytomegalovirus Infections →
- Infection Reactivation — all drugs for Infection Reactivation →
- Stem Cell Transplant Complications — all drugs for Stem Cell Transplant Complications →
Sponsor
Chinese PLA General Hospital
Who can join
Adults 14 to 65, any sex, with Cytomegalovirus Infections or Infection Reactivation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Anti-thymocyte globulin (ATG) is widely used in allogeneic hematopoietic stem cell transplantation to prevent severe graft-versus-host disease (GVHD) and graft failure. However, overexposure to ATG may increase cytomegalovirus (CMV), Epstein-Barr virus (EBV) reactivation, non-relapse mortality, and disease recurrence. A targeted dosing strategy was established based on ATG concentration monitoring and conducted a phase 2 trial to evaluate the safety and efficacy of the dosing strategy in adult unmanipulated haplo-PBSCT, a encouraging result was attained. In this trial, The ATG-targeted dosing strategy was extended to adult unrelated donor allogeneic hematopoietic stem cell transplantation, ATG was administered for 4 days (-5 days to -2 days) during conditioning. The ATG doses on-3 days and- 2days were adjusted by our dosing strategy to achieve the optimal ATG exposure. The primary endpoint was CMV reactivation on +180 days.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Reduced cytomegalovirus reactivation and viremia without increasing GVHD after URD-PBSCT: A prospective study using targeted ATG dosing strategy.
Chen S, Wang L, Luan S, Wang H, et al · · 2026 · PMID 41624481 · DOI 10.1016/j.cpt.2025.04.001
Verify or expand the search:
- PubMed search for NCT06572462
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cytomegalovirus Infections
Currently open trials in the same condition.
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- NCT06909110 — Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With · Phase 1, PHASE2 · recruiting
- NCT06694428 — Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infecti · recruiting
- NCT06812598 — Efficacy of Extended Letermovir Prophylaxis to Prevent CMV Reactivation in High-Risk Chinese Adults Undergoing Allogenei · NA · recruiting
- NCT06554197 — Evaluation of CMV/EBV-CMI in Haploid HSCT · recruiting
Other Chinese PLA General Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06572462 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese PLA General Hospital
- Last refreshed: 3 December 2024
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