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Recruiting NCT03844360

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

Phase IV Interventional Hematological Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bortezomib, Eltrombopag, Imatinib, dasatinib.
Who it may be relevant to
Registry conditions: Hematological Neoplasms. Basic parameters: 1 Day — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Bortezomib
    bortezomib was administered follow the doctor's advice.
  • Drug Eltrombopag
    eltrombopag was administered follow the doctor's advice.
  • Drug Imatinib
    imatinib was administered follow the doctor's advice.
  • Drug dasatinib
    dasatinib was administered follow the doctor's advice.
  • Drug Pegaspargase
    pegaspargase was administered follow the doctor's advice.
  • 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.

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • plasma concentration of anti-infective drug [Time frame: through study completion, an average of 14 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University — Xuzhou
  • State Key Laboratory of Experimental Haematology, Department of Paediatric Haematology, In — Tanjin

Publications

  • 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. PMID 38497347
  • 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. PMID 34240339

Identifiers

NCT: NCT03844360 · Antineoplastic Drugs001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗