Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called rabbit anti-human T-lymphocyte immunoglobulin (ATLG) compared to another treatment called anti-thymocyte globulin (ATG) for patients undergoing a specific type of stem cell transplantation. This transplantation is often the only cure for certain blood cancers like leukemia and lymphoma. The researchers want to see if ATLG can help patients recover their immune system more effectively after the transplant, potentially reducing the risk of serious infections and other complications.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of certain blood cancers. They should be preparing for their first stem cell transplant and have stable organ function. Participants will be closely monitored after the transplantation to see how well their immune system is recovering. The trial is not yet recruiting participants, but it aims to provide valuable information on how ATLG might improve recovery for patients facing these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.