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

NCT06895538 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Phase 2/3

Started

2025-05-03

Last updated

2026-08-05

Condition(s) studied

LeukemiaMDSLymphoma

Investigational drug(s) / intervention(s)

Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG)

Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG): Patients in the ATLG arm receive ATLG instead of ATG as part of the routine conditioning regimen before allo-HSCT; ATLG is given intravenously by infusion for 4 consecutive days, after which they undergo routine transplantation.

Study 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 "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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of viral infections after hematopoietic stem cell transplantation — From enrollment to 1 year after allo-HSCT
Incidence of CMV reactivation (CMV DNA ≥10\^3) and CMV disease, incidence of EBV reactivation (incidence of EBV DNA ≥10\^5) and lymphoproliferative disorders (PTLD), incidence of hemorrhagic cystitis, incidence of herpes simplex, adenovirus, or other viruses in both groups.

Trial sites (1)

Facility	City	Region	Status
Peking University First Hospital	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06895538 on ClinicalTrials.gov ↗ ← All trials in China