Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
1 other identifier
interventional
1,500
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2016
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2016
CompletedFirst Submitted
Initial submission to the registry
February 12, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMarch 30, 2025
April 1, 2019
9.9 years
February 12, 2019
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
change of plasma concentration of bortezomib
To detect the plasma concentrations of bortezomib after administration
at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration
change of plasma concentration of eltrombopag
To detect the plasma concentrations of eltrombopag after administration
at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration
change of plasma concentration of imatinib
To detect the plasma concentrations of imatinib after administration
at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration
change of plasma concentration of dasatinib
To detect the plasma concentrations of dasatinib after administration
at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration
change of plasma concentration of pegaspargase
To detect the plasma concentrations of pegaspargase after administration
at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration
plasma concentration of anti-infective drug
To detect the plasma concentrations of anti-infective drug after administration
through study completion, an average of 14 days
Study Arms (1)
Antineoplastic Drugs and Anti-infective Drugs
EXPERIMENTALBortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
Interventions
bortezomib was administered follow the doctor's advice.
eltrombopag was administered follow the doctor's advice.
imatinib was administered follow the doctor's advice.
dasatinib was administered follow the doctor's advice.
pegaspargase was administered follow the doctor's advice.
anti-infective drugs was administered follow the doctor's advice.
pegaspargase was administered follow the doctor's advice.
Eligibility Criteria
You may qualify if:
- Patients must be diagnosed with hematological neoplasms
- Antineoplastic drugs or anti-infective drugs used as part of regular treatment
You may not qualify if:
- expected survival time less than the treatment cycle;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
State Key Laboratory of Experimental Haematology, Department of Paediatric Haematology, Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tanjin, Tianjin Municipality, 300020, China
Related Publications (2)
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.
PMID: 38497347DERIVEDYang 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: 34240339DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Zhao, Ph.D
Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor; Head of department of clinical pharmacy and pharmacology
Study Record Dates
First Submitted
February 12, 2019
First Posted
February 18, 2019
Study Start
January 31, 2016
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
March 30, 2025
Record last verified: 2019-04