RecruitingPhase 2Phase 3NCT06895538

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

An Exploratory, Non-Randomized, Controlled Study of the Effect of Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) Versus Anti-Thymocyte Immunoglobulin (ATG) on Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematologic Diseases


Sponsor

Peking University First Hospital

Enrollment

24 participants

Start Date

May 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of antibody-based medications — ATLG and ATG — that are used before bone marrow or stem cell transplants to help prevent the immune system from attacking the new cells (a condition called graft-versus-host disease). Researchers want to find out which medication leads to better immune recovery and fewer complications after transplantation for blood cancers. **You may be eligible if...** - You are 18 years or older - You have a confirmed blood cancer (such as leukemia or lymphoma) - You are undergoing your first allogeneic (donor-based) stem cell or bone marrow transplant - You are physically well enough to participate (ECOG score 0–2) - Your liver, kidney, and heart function meet the required levels **You may NOT be eligible if...** - You have had a previous stem cell or organ transplant - You have severe organ dysfunction (liver, kidney, or heart failure) - You have an active, uncontrolled infection - You are pregnant or breastfeeding - You have certain other serious medical conditions that could affect your safety in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRabbit 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.


Locations(1)

Peking University First Hospital

Beijing, China

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NCT06895538


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