Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03844360

Enrollment

1500

Registered

2019-02-18

Start date

2016-01-31

Completion date

2026-12-31

Last updated

2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Neoplasms

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.

Interventions

DRUGBortezomib

bortezomib was administered follow the doctor's advice.

DRUGEltrombopag

eltrombopag was administered follow the doctor's advice.

DRUGImatinib

imatinib was administered follow the doctor's advice.

DRUGdasatinib

dasatinib was administered follow the doctor's advice.

DRUGPegaspargase

pegaspargase was administered follow the doctor's advice.

DRUGAnti-Infective Drugs

anti-infective drugs was administered follow the doctor's advice.

DRUGPEGylated Recombinant Human Granulocyte Colony-Stimulating Factor

pegaspargase was administered follow the doctor's advice.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
change of plasma concentration of bortezomib	at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration	To detect the plasma concentrations of bortezomib after administration
change of plasma concentration of eltrombopag	at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration	To detect the plasma concentrations of eltrombopag after administration
change of plasma concentration of imatinib	at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration	To detect the plasma concentrations of imatinib after administration
change of plasma concentration of dasatinib	at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration	To detect the plasma concentrations of dasatinib after administration
change of plasma concentration of pegaspargase	at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration	To detect the plasma concentrations of pegaspargase after administration
plasma concentration of anti-infective drug	through study completion, an average of 14 days	To detect the plasma concentrations of anti-infective drug after administration

Countries

China

Contacts

Primary ContactWei Zhao, Ph.D

zhao4wei2@hotmail.com86053188383308

Backup ContactYan H Shi, Ph.D