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

January 7, 2020 updated by: Wei Zhao
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tanjin, Tianjin, China, 300020
        • Recruiting
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Zhao

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Wei Zhao, Ph.D, Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2016

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antineoplastic Drugs001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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