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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematological Neoplasms

Intervention / Treatment
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* Drug: Bortezomib
* Drug: Eltrombopag
* Drug: Imatinib
* Drug: dasatinib
* Drug: Pegaspargase
* Drug: Anti-Infective Drugs
* Drug: PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antineoplastic Drugs and Anti-infective Drugs<br>Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. | Drug: Bortezomib<br>* bortezomib was administered follow the doctor's advice.<br>* Other names: Velcade;Drug: Eltrombopag<br>* eltrombopag was administered follow the doctor's advice.<br>* Other names: promacta;Drug: Imatinib<br>* imatinib was administered follow the doctor's advice.<br>* Other names: Gleevec;Drug: dasatinib<br>* dasatinib was administered follow the doctor's advice.<br>* Other names: sprycel;Drug: Pegaspargase<br>* pegaspargase was administered follow the doctor's advice.<br>* Other names: Oncaspar;Drug: Anti-Infective Drugs<br>* anti-infective drugs was administered follow the doctor's advice.<br>Drug: PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor<br>* pegaspargase was administered follow the doctor's advice.<br>* Other names: PEG-rhG-CSF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |