Hematopoietic Stem Cell Transplantation
Conditions
Interventions
Intervention group (Research two):Model-based dosing
control group (Research two):Weight-based dosing
Observation Group (Research one):None
Sponsors
Shenzhen Children’s Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Research one: 2023/09/01-2024/7/30 Age range: 2-18 years old; Severe TM underwent Haplo SCT and Bu pre-treatment; Voluntarily sign the informed consent form and agree to participate in this study; 2.Research two: Control group: From October 1, 2024 to December 31, 2025 our center and cooperative units diagnosed severe TM, implemented a traditional weight based dosing regimen, and performed Haplo SCT on children in parallel; Age range: 2-18 years old; The basic information of the patient is complete, and the guardian voluntarily signs an informed consent form, agreeing to participate in this study; 3.Research two: Intervention group:From October 1, 2024 to December 31, 2025, our center and partner units diagnosed severe TM, implemented a model-based medication regimen, and performed Haplo SCT on children in parallel; Age range: 2-18 years old; The basic information of the patient is complete, and the guardian voluntarily signs an informed consent form, agreeing to participate in this study.
Exclusion criteria
Exclusion criteria: 1.Research one: Allergic to Bu; No monitoring of Bu blood drug concentration was conducted; Abnormal blood drug concentration monitoring results; 2.Research two: Children with Bu allergy; Children who did not undergo blood drug concentration monitoring during the use of Bu; Children with abnormal blood drug concentration monitoring results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target AUC compliance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target Css compliance rate;aGVHD grading and incidence rate; | — |
Countries
China
Contacts
Public ContactXuejuan Li
Shenzhen Children’s Hospital
Outcome results
None listed