ATG Individualized Dosing Model in URD-PBSCT.

Recruiting now · Phase 2

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

In brief

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.

Key facts

Study ID: NCT06572462
Run by: Chinese PLA General Hospital
People needed: 30
Starts: 2020-12-31
Expected to finish: 2025-06-30
Last updated by the study team: 2024-12-03

Who can join

Age: 14 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with malignant hematological tumors who have indications for allogeneic hematopoietic stem cell transplantation.
HLA-matched unrelated donor
Patient age ≥14 years old and ≤65 years old
ALT and AST ≤ 2.5 times the upper limit of normal values, bilirubin ≤ 2 times the upper limit of normal values
Creatinine ≤ high limit of normal value
No uncontrollable infection or serious mental illness
Physical strength score is 0-2 (ECOG)
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You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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