Status:
UNKNOWN
Target Busulfan Exposure in Children With HSCT in China
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Children's Hospital of Soochow University
Children's Hospital of Fudan University
Conditions:
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
Up to 18 years
Brief 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 Chi...
Detailed Description
Objectives To evaluate the influence factors of BU metabolism in children and the correlation between BU exposure and post-transplant clinical results (efficacy and safety) to establish the optimal BU...
Eligibility Criteria
Inclusion
- The subjects or their legal guardians voluntarily sign the informed consent, and can complete the study in accordance with the requirements of the program;
- No age or gender restriction;
- Patients with blood disease confirmed by histopathology or cytology;
- BU-based regimen will be adopted. The BU administration regimen was four times a day (Q6h), continuous intravenous infusion for 2 hours, 3 or 4 days in a row.
Exclusion
- Patients with difficulty in vein blood sampling (if there is a needle, blood history);
- BU TDM was not performed during the treatment;
- Subjects who are considered unfit to participate in the trail by the investigator.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04786002
Start Date
November 1 2020
End Date
June 1 2023
Last Update
March 10 2021
Active Locations (1)
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1
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006