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

NCT ID: NCT03844360

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hematological Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Antineoplastic Drugs and Anti-infective Drugs

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

Group Type EXPERIMENTAL

Bortezomib

Intervention Type DRUG

bortezomib was administered follow the doctor's advice.

Eltrombopag

Intervention Type DRUG

eltrombopag was administered follow the doctor's advice.

Imatinib

Intervention Type DRUG

imatinib was administered follow the doctor's advice.

dasatinib

Intervention Type DRUG

dasatinib was administered follow the doctor's advice.

Pegaspargase

Intervention Type DRUG

pegaspargase was administered follow the doctor's advice.

Anti-Infective Drugs

Intervention Type DRUG

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

PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor

Intervention Type DRUG

pegaspargase was administered follow the doctor's advice.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bortezomib

bortezomib was administered follow the doctor's advice.

Intervention Type DRUG

Eltrombopag

eltrombopag was administered follow the doctor's advice.

Intervention Type DRUG

Imatinib

imatinib was administered follow the doctor's advice.

Intervention Type DRUG

dasatinib

dasatinib was administered follow the doctor's advice.

Intervention Type DRUG

Pegaspargase

pegaspargase was administered follow the doctor's advice.

Intervention Type DRUG

Anti-Infective Drugs

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

Intervention Type DRUG

PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor

pegaspargase was administered follow the doctor's advice.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Velcade promacta Gleevec sprycel Oncaspar PEG-rhG-CSF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

Wei Zhao

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wei Zhao

Professor; Head of department of clinical pharmacy and pharmacology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wei Zhao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status COMPLETED

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

Tanjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wei Zhao, Ph.D

Role: CONTACT

86053188383308

Yan H Shi, Ph.D

Role: CONTACT

86053188383308

References

Explore related publications, articles, or registry entries linked to this study.

Zhang W, Chang LX, Zhao BB, Zheng Y, Shan DD, Tang BH, Yang F, Zhou Y, Hao GX, Zhang YH, van den Anker J, Zhu XF, Zhang L, Zhao W. Efficacy, Safety, and Population Pharmacokinetics of Eltrombopag in Children with Different Severities of Aplastic Anemia. J Clin Pharmacol. 2024 Aug;64(8):932-943. doi: 10.1002/jcph.2430. Epub 2024 Mar 18.

Reference Type DERIVED
PMID: 38497347 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34240339 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Antineoplastic Drugs001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of 2nd Gen TKI in CML
NCT02222272 COMPLETED
Lenalidomide Plus Chemotherapy for AML
NCT01681537 COMPLETED PHASE1