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

NCT06895538 | Recruiting Phase 2 DMC

• 1 other identifier: PKUFH 2024 644-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 "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.

Conditions

Leukemia; MDS; Lymphoma

Keywords

ATLG; ATG; immune reconstitution; allo-HSCT

Outcome Measures

Primary Outcomes (1)

• Incidence of viral infections after hematopoietic stem cell transplantation

  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.

  From enrollment to 1 year after allo-HSCT

Secondary Outcomes (9)

• Incidence and severity of acute GVHD (aGVHD)

  From enrollment to the 100days after transplantation

• Incidence and Severity of Chronic Graft-Versus-Host Disease (cGVHD)

  With a minimum follow-up of 2 years for all enrolled patients

• Immune Reconstitution Profiles Post-Transplantation

  From enrollment to the one year after trandplant

• Overall Survival (OS)

  From enrollment to the 2 years post-transplantation.

• Disease-Free Survival (DFS)

  From enrollment to the 2 years post-transplantation

Study Arms (1)

Anti-human T-lymphocyte rabbit immunoglobulin (ATLG)

EXPERIMENTAL

ATLG will be given as a substitute for ATG in the conditioning regimen for hematologic malignancy patients who are undergoing allo-HSCT

Drug: Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG)

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.

Anti-human T-lymphocyte rabbit immunoglobulin (ATLG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）Age ≧18 years, gender is not limited;
• ）Histologically or cytologically confirmed diagnosis of malignant hematologic diseases;
• \) First time undergoing allogeneic hematopoietic stem cell transplantation;
• \) ECOG score 0-2;
• \) 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;
• \) Expected survival is longer than 12 weeks;
• \) The subjects will voluntarily and strictly comply with the requirements of the study protocol and will sign a written informed consent form.

You may not qualify if:

• \) Prior treatment with ATG, ALG, or ATLG drugs within the past six months;
• \) Allergic to any component of ATLG or ATG;
• \) Bacterial, viral, parasitic, or mycobacterial infections not adequately controlled by treatment, i.e., inability to undergo hematopoietic stem cell transplantation due to severe infection.
• \) 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).
• \) 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

RECRUITING

MeSH Terms

Conditions

Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jialin Zhu, MD

CONTACT

+86-13671375500; julie920219@163.com

Bingjie Wang, MD

CONTACT

+86-15201286579; wbj880202@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: May 3, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 5, 2026

Record last verified: 2025-12

Locations

CN (1)