drugset / Trial / NCT03844360
Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
Phase 4
Recruiting
1500 enrolled
Wei Zhao
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collab
NaSingle-groupOpen-labelTreatment
Summary
The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs in children with hematoplastic disease.
Timeline
- Start
- 2016-01-31
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
Publications
- Zhang W, Chang LX, Zhao BB, Zheng Y, Shan DD, Tang BH, Yang F, Zhou Y, Hao GX, Zhang YH, van den Anker J, Zhu XF, Zhang L, Zhao W. Efficacy, Safety, and Population Pharmacokinetics of Eltrombopag in Children with Different Severities of Aplastic Anemia. J Clin Pharmacol. 2024 Aug;64(8):932-943. doi: 10.1002/jcph.2430. Epub 2024 Mar 18.
- Yang F, Zhang L, Zhao BB, Zhang JL, Liu XT, Li X, Tang BH, Zhou Y, Yang XM, van den Anker J, Zhu XF, Zhao W. Population Pharmacokinetics and Safety of Dasatinib in Chinese Children with Core-Binding Factor Acute Myeloid Leukemia. Clin Pharmacokinet. 2022 Jan;61(1):71-81. doi: 10.1007/s40262-021-01054-6. Epub 2021 Jul 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | — | — |
| Subject | Eltrombopag | Small molecule | — | — |
| Subject | Imatinib | Small molecule | — | — |
| Subject | Pegaspargase | Protein / enzyme biologic | — | — |
| Subject | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Subject | dasatinib anhydrous | Small molecule | 60 mg/m2 | Oral |
| Subject | dasatinib anhydrous | Small molecule | 80 mg/m2 | Oral |