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

Primary Purpose

Hematological Neoplasms

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bortezomib
Eltrombopag
Imatinib
dasatinib
Pegaspargase
Anti-Infective Drugs
PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor
Sponsored by
Wei Zhao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Neoplasms

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • 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 CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antineoplastic Drugs and Anti-infective Drugs

Arm Description

Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.

Outcomes

Primary Outcome Measures

change of plasma concentration of bortezomib
To detect the plasma concentrations of bortezomib after administration
change of plasma concentration of eltrombopag
To detect the plasma concentrations of eltrombopag after administration
change of plasma concentration of imatinib
To detect the plasma concentrations of imatinib after administration
change of plasma concentration of dasatinib
To detect the plasma concentrations of dasatinib after administration
change of plasma concentration of pegaspargase
To detect the plasma concentrations of pegaspargase after administration
plasma concentration of anti-infective drug
To detect the plasma concentrations of anti-infective drug after administration

Secondary Outcome Measures

Full Information

First Posted
February 12, 2019
Last Updated
January 7, 2020
Sponsor
Wei Zhao
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03844360
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Zhao
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antineoplastic Drugs and Anti-infective Drugs
Arm Type
Experimental
Arm Description
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
bortezomib was administered follow the doctor's advice.
Intervention Type
Drug
Intervention Name(s)
Eltrombopag
Other Intervention Name(s)
promacta
Intervention Description
eltrombopag was administered follow the doctor's advice.
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec
Intervention Description
imatinib was administered follow the doctor's advice.
Intervention Type
Drug
Intervention Name(s)
dasatinib
Other Intervention Name(s)
sprycel
Intervention Description
dasatinib was administered follow the doctor's advice.
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Other Intervention Name(s)
Oncaspar
Intervention Description
pegaspargase was administered follow the doctor's advice.
Intervention Type
Drug
Intervention Name(s)
Anti-Infective Drugs
Intervention Description
anti-infective drugs was administered follow the doctor's advice.
Intervention Type
Drug
Intervention Name(s)
PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor
Other Intervention Name(s)
PEG-rhG-CSF
Intervention Description
pegaspargase was administered follow the doctor's advice.
Primary Outcome Measure Information:
Title
change of plasma concentration of bortezomib
Description
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
Title
change of plasma concentration of eltrombopag
Description
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
Title
change of plasma concentration of imatinib
Description
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
Title
change of plasma concentration of dasatinib
Description
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
Title
change of plasma concentration of pegaspargase
Description
To detect the plasma concentrations of pegaspargase after administration
Time Frame
at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration
Title
plasma concentration of anti-infective drug
Description
To detect the plasma concentrations of anti-infective drug after administration
Time Frame
through study completion, an average of 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhao, Ph.D
Phone
86053188383308
Email
zhao4wei2@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yan H Shi, Ph.D
Phone
86053188383308
Email
zhao4wei2@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhao, Ph.D
Organizational Affiliation
Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Tanjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
34240339
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.
Results Reference
derived

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

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