Targeted Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation

NCT05166967 | Completed Phase 3

• 1 other identifier: S2020-484-02
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the response and toxicity rate of two different dosages (Individualized dosage VS. fixed dosage) of ATG as a prophylaxis for acute GVHD in haploidentical peripheral blood stem cell transplantation (haplo-PBSCT).

Conditions

Haploidentical Hematopoietic Stem Cell Transplantation

Keywords

ATG; Haplo-HSCT

Outcome Measures

Primary Outcomes (1)

• GVHD-free and relapse-free survival (GRFS)

  GRFS is defined as a composite endpoint of death from any cause, disease relapse, grade III-IV acute GVHD, or moderate to severe chronic GVHD requiring systemic immunosuppression therapy.

  12 months after transplantation

Secondary Outcomes (12)

• Cumulative incidences of CMV reactivation

  6 months after transplantation

• Incidence of CMV disease

  6 months after transplantation

• Cumulative incidences of EBV reactivation

  6 months after transplantation

• Cumulative incidences of PTLD(posttransplant lymphoproliferative disorders)

  6 months after transplantation

• Cumulative incidences of aGVHD

  365 days after transplantation

Study Arms (2)

Individual dose of ATG

EXPERIMENTAL

Individual dose of ATG: Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on pharmacokinetic index, within a range of 6 mg/kg to 13mg/kg), and the active ATG concentration ranges from 110 to 148.5UE/ml.

Drug: Individual Antithymocyte globulin

Fixed dose of ATG

ACTIVE COMPARATOR

A total amount of 10mg/kg ATG was divided into 4 days (from day -5 to day -2). The specific usage: 1.5mg/kg for day -5, 2.5mg/kg for day -4 and day -3, 3.5 mg/kg for day -2.

Drug: Antithymocyte globulin

Interventions

Individual Antithymocyte globulin DRUG

Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on pharmacokinetic index, within a range of 6 mg/kg to 13mg/kg). Prophylaxis against graft versus-host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate.

Individual dose of ATG

Antithymocyte globulin DRUG

A 10mg/kg total dose of antithymocyte globulin (ATG) was added to conditioning regimens for 4 days (from day -5 to day -2). Prophylaxis against graft versus-host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate.

Fixed dose of ATG

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients should have the indication of Haploidentical hematopoietic stem cell transplant.
• \. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

You may not qualify if:

• Patients with any conditions not suitable for the trial (investigators' decision).

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Peking University People's Hospital, Peking University Institute of Hematology: collaborator
• Department of Hematology, The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Interventions

Antilymphocyte Serum

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Daihong Liu, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Random Group Assignment

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 22, 2021
• Study Start: January 1, 2022
• Primary Completion: February 16, 2024
• Study Completion: July 29, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-07

Locations

CN (1)