NCT06572462 ATG Individualized Dosing Model in URD-PBSCT.
| NCT ID | NCT06572462 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Cytomegalovirus Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2020-12-31 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2020-12-31 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
diahong Liu, MD
PRINCIPAL INVESTIGATOR
The First Medical Center of Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT06572462 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 Years, studying Cytomegalovirus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06572462 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06572462 currently recruiting?
Yes, NCT06572462 is actively recruiting participants. Contact the research team at csto301@163.com for enrollment information.
Where is the NCT06572462 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06572462 clinical trial?
NCT06572462 is sponsored by Chinese PLA General Hospital. The principal investigator is diahong Liu, MD at The First Medical Center of Chinese PLA General Hospital. The trial plans to enroll 30 participants.