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Targeted Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation

NCT05166967 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-01-21

No results posted yet for this study

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

Interventions

DRUG

Individual Antithymocyte globulin

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.

DRUG

Antithymocyte globulin

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.

Sponsors & Collaborators

  • Peking University People's Hospital, Peking University Institute of Hematology

    collaborator UNKNOWN

  • Department of Hematology, The First Affiliated Hospital of Zhengzhou University

    collaborator UNKNOWN

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Daihong Liu, Doctor · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-02-16
Completion
2025-07-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166967 on ClinicalTrials.gov