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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-18
SponsorWei Zhao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be diagnosed with hematological neoplasms

Antineoplastic drugs or anti-infective drugs used as part of regular treatment

Disqualifiers

expected survival time less than the treatment cycle;

patients with other factors that researcher considers unsuitable for inclusion.

Trial design

Design model

Single group

Treatments tested in this trial

  • Bortezomib

    Drug

    bortezomib was administered follow the doctor's advice.

  • Eltrombopag

    Drug

    eltrombopag was administered follow the doctor's advice.

  • Imatinib

    Drug

    imatinib was administered follow the doctor's advice.

  • dasatinib

    Drug

    dasatinib was administered follow the doctor's advice.

  • Pegaspargase

    Drug

    pegaspargase was administered follow the doctor's advice.

  • Anti-Infective Drugs

    Drug

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

  • PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor

    Drug

    pegaspargase was administered follow the doctor's advice.

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Antineoplastic Drugs and Anti-infective DrugsExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

change of plasma concentration of bortezomib

To detect the plasma concentrations of bortezomib after administration

Time frame
at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration
2

change of plasma concentration of eltrombopag

To detect the plasma concentrations of eltrombopag after administration

Time frame
at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration
3

change of plasma concentration of imatinib

To detect the plasma concentrations of imatinib after administration

Time frame
at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration
4

change of plasma concentration of dasatinib

To detect the plasma concentrations of dasatinib after administration

Time frame
at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wei Zhao

Lead sponsor

Shandong University

Sponsor institution

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator