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

March 25, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Completed
        • Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wei Zhao

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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