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

Hematological Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03844360
• Other study ID #: Antineoplastic Drugs001
• Status: Recruiting
• Phase: Phase 4
• Start date: January 31, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2019
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Neoplasms

Intervention

Drug:
• Bortezomib
bortezomib was administered follow the doctor's advice.
• Eltrombopag
eltrombopag was administered follow the doctor's advice.
• Imatinib
imatinib was administered follow the doctor's advice.
• dasatinib
dasatinib was administered follow the doctor's advice.
• Pegaspargase
pegaspargase was administered follow the doctor's advice.
• Anti-Infective Drugs
anti-infective drugs was administered follow the doctor's advice.
• PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor
pegaspargase was administered follow the doctor's advice.

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Wei Zhao	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of plasma concentration of bortezomib	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
Primary	change of plasma concentration of eltrombopag	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
Primary	change of plasma concentration of imatinib	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
Primary	change of plasma concentration of dasatinib	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
Primary	change of plasma concentration of pegaspargase	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
Primary	plasma concentration of anti-infective drug	To detect the plasma concentrations of anti-infective drug after administration	through study completion, an average of 14 days