Clinical trial · Interventional
Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
NCT03844360CI-TRIAL-00087839recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-Infective Drugs | Drug | — | UNRESOLVED |
| Bortezomib | Drug | Bortezomib | ALIAS |
| dasatinib | Drug | Dasatinib | ALIAS |
| Eltrombopag | Drug | — | UNRESOLVED |
| Imatinib | Drug | Imatinib | ALIAS |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
| PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Antineoplastic Drugs and Anti-infective Drugs
- description
- Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
- interventionNames
- Drug: Bortezomib
- Drug: Eltrombopag
- Drug: Imatinib
- Drug: dasatinib
- Drug: Pegaspargase
- Drug: Anti-Infective Drugs
- Drug: PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor
Primary outcomes (6)
- measure
- change of plasma concentration of bortezomib
- timeFrame
- at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration
- description
- To detect the plasma concentrations of bortezomib after administration
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be diagnosed with hematological neoplasms * Antineoplastic drugs or anti-infective drugs used as part of regular treatment Exclusion Criteria: * expected survival time less than the treatment cycle; * patients with other factors that researcher considers unsuitable for inclusion.
References
Publications (2)
- DERIVEDZhang 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. PMID 38497347
- DERIVEDYang 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. PMID 34240339