Actively Recruiting
ATG Individualized Dosing Model in URD-PBSCT.
Led by Chinese PLA General Hospital · Updated on 2024-12-03
30
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ATG Individualized Dosing Model in URD-PBSCT.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with malignant hematological tumors indicated for allogeneic hematopoietic stem cell transplantation
- HLA-matched unrelated donor
- Age between 14 and 65 years old
- ALT and AST less than or equal to 2.5 times the upper limit of normal
- Bilirubin less than or equal to 2 times the upper limit of normal
- Creatinine within normal limits
- No uncontrollable infection or serious mental illness
- Physical strength score 0 to 2 (ECOG)
- Signed informed consent form
You will not qualify if you...
- Unrelated donor who is not HLA matched
- No indication for allogeneic hematopoietic stem cell transplantation
- Age less than 14 years or greater than 65 years
- Donor or recipient is pregnant
- Presence of mental illness or other conditions preventing study participation as planned
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Hematology, First Medical Center of Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
S
Sheng Chen, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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