Clinical trial NCT03844360: Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
Official title: Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hematological Neoplasms
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2019-02-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs based on the opportunistic sampling strategy in children with confirmed or suspected hematological neoplasms.

Eligibility criteria: 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.

Primary outcomes:
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
measure: change of plasma concentration of eltrombopag
timeFrame: at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration
measure: change of plasma concentration of imatinib
timeFrame: at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration
measure: change of plasma concentration of dasatinib
timeFrame: at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration
measure: change of plasma concentration of pegaspargase
timeFrame: at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration
measure: plasma concentration of anti-infective drug
timeFrame: through study completion, an average of 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Tanjin
country: China
facility: 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
state: Tianjin
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.