Actively Recruiting
Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy
Led by Peking University First Hospital · Updated on 2025-06-11
24
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Allogeneic hematopoietic stem cell transplantation is the only curative treatment for malignant hematologic diseases. However, immune rejection is a major limitation in its application. In the "Beijing Protocol", the use of granulocyte colony-stimulating factor (G-CSF) in combination with anti-thymocyte globulin (ATG) can achieve "everyone has a donor". The use of ATG, however, can interfere with the recovery of immune function after transplantation, increasing the risk of life-threatening complications such as viral infections or graft-versus-host disease. Rabbit anti-human T-lymphocyte immunoglobulin (ATLG) is currently approved for the prevention of organ transplant rejection, which is produced differently from ATG. Previous studies have shown that transplant preconditioning with ATLG is effective in preventing graft-versus-host disease and even reduces the incidence of cytomegalovirus, etc. after transplantation. In this study, we will prospectively apply containing ATLG in a cohort of allogeneic hematopoietic stem cell transplantation for malignant hematologic diseases and dynamically observe the state of immune reconstitution of patients after transplantation. We will also compare it with a matched cohort of conventional combined ATGs during the same period to explore the impact of ATLG on immune reconstitution after transplantation.
CONDITIONS
Official Title
Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Confirmed diagnosis of malignant hematologic diseases by histology or cytology
- First time undergoing allogeneic hematopoietic stem cell transplantation
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2
- Adequate liver, kidney, heart, and lung function including: serum creatinine ≤ 1.5 times upper limit of normal (ULN); left ventricular ejection fraction ≥ 45%; blood oxygen saturation above 91%; total bilirubin ≤ 2 × ULN; ALT and AST ≤ 3 × ULN (or ≤ 5 × ULN if due to disease)
- Expected survival longer than 12 weeks
- Willingness to comply with study protocol and provide informed consent
You will not qualify if you...
- Prior treatment with ATG, ALG, or ATLG within the past six months
- Allergy to any component of ATLG or ATG
- Uncontrolled bacterial, viral, parasitic, or mycobacterial infections preventing transplantation
- Women who are pregnant or breastfeeding, or unwilling/unable to use contraception if of childbearing potential
- Participation in another clinical trial involving investigational drugs or devices within 30 days prior to baseline
- Any other condition that the investigator judges may interfere with study conduct or results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
Research Team
J
Jialin Zhu, MD
CONTACT
B
Bingjie Wang, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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