Status:
RECRUITING
Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy
Lead Sponsor:
Peking University First Hospital
Conditions:
Leukemia
MDS
Eligibility:
All Genders
18+ years
Brief Summary
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 "Beijin...
Detailed Description
Hematological malignancies (referred to as malignant hematological diseases) are a class of major diseases that pose a significant threat to human health. Currently, allogeneic hematopoietic stem cell...
Eligibility Criteria
Inclusion
- 1）Age ≧18 years, gender is not limited;
- 2）Histologically or cytologically confirmed diagnosis of malignant hematologic diseases;
- 3\) First time undergoing allogeneic hematopoietic stem cell transplantation;
- 4\) ECOG score 0-2;
- 5\) Hepatic and renal function, cardiopulmonary function meet the following requirements.
- Serum creatinine ≤ 1.5 ULN; ②Left ventricular ejection fraction ≥ 45%;
- Blood oxygen saturation \>91%;
- Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 3 × ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltrates or bile duct obstruction), in the judgment of the investigator, the values may be adjusted to ≤ 5 × ULN;
- 6\) Expected survival is longer than 12 weeks;
- 7\) The subjects will voluntarily and strictly comply with the requirements of the study protocol and will sign a written informed consent form.
Exclusion
- 1\) Prior treatment with ATG, ALG, or ATLG drugs within the past six months;
- 2\) Allergic to any component of ATLG or ATG;
- 3\) Bacterial, viral, parasitic, or mycobacterial infections not adequately controlled by treatment, i.e., inability to undergo hematopoietic stem cell transplantation due to severe infection.
- 4\) Women who are pregnant or breastfeeding, or participants of childbearing potential who are unwilling or unable to use effective methods of contraception; 5) Participants enrolled in another clinical trial (of any investigational drug or device) within 30 days prior to the subject's baseline visit. (Subjects enrolled in observational studies are eligible to participate).
- 6\) Any other circumstance that, in the judgment of the investigator, may interfere with the conduct of the clinical trial and the determination of the results of the trial.
Key Trial Info
Start Date :
May 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06895538
Start Date
May 3 2025
End Date
January 1 2027
Last Update
June 11 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, China, 100034