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

Sponsor
Peking University First Hospital
Study ID
NCT06895538
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) — DRUG
    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 Details

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.

Key Dates

First listed
Mar 26, 2025
Start date
May 3, 2025
Status verified
May 2025
Primary completion
Jan 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
24 participants (estimated)

Arms

  • Arm: Anti-human T-lymphocyte rabbit immunoglobulin (ATLG)
    ATLG will be given as a substitute for ATG in the conditioning regimen for hematologic malignancy patients who are undergoing allo-HSCT

Primary Outcome Measure

Incidence of viral infections after hematopoietic stem cell transplantation [ Time Frame: From enrollment to 1 year after allo-HSCT ]

Central Contacts

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