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Target Busulfan Exposure in Children With HSCT in China

NCT04786002 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-03-10

No results posted yet for this study

Summary

Objectives To evaluate the correlation between BU exposure and post-transplant clinical results (efficacy and safety) to establish the optimal BU treatment window for myeloablative conditioning in Chinese pediatrics, provide theoretical basis and the new strategy for BU individualized dosage, further optimize transplant treatment and reduce drug-related toxicity.

Population 500 participants of any sex between the age of 0.1 and 18 years. Patients receiving the BU-based myeloablative conditioning before transplantation.

Endpoint primary To establish BU pop-PK model and analyze the association between BU AUC and event-free survival (EFS)or overall survival (OS) after transplantation in Chinese pediatrics.

Secondary The investigators are also interested in transplantation-related mortality (TRM), acute toxicity and chronic GvHD.

Conditions

  • Hematopoietic Stem Cell Transplantation

Interventions

DRUG

Busulfan

The BU administration regimen was four times a day (Q6h), continuous intravenous infusion for 2 hours, 3 or 4 days in a row.

Sponsors & Collaborators

  • Children's Hospital of Soochow University

    collaborator OTHER

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • Guangzhou Women and Children's Medical Center

    collaborator OTHER

  • West China Second University Hospital

    collaborator OTHER

  • Beijing Children's Hospital

    collaborator OTHER

  • Shenzhen Children's Hospital

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Liyan Miao, PhD · The First Affiliated Hospital of Soochow University

  • Shaoyan Hu, MD · Children's Hospital of Soochow University

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-12-01
Completion
2023-06-01

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 NCT04786002 on ClinicalTrials.gov