Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children with Hematoplastic Disease
- Conditions
- Hematological Neoplasms
- Interventions
- Registration Number
- NCT03844360
- Lead Sponsor
- Wei Zhao
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Patients must be diagnosed with hematological neoplasms
- Antineoplastic drugs or anti-infective drugs used as part of regular treatment
- expected survival time less than the treatment cycle;
- patients with other factors that researcher considers unsuitable for inclusion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Antineoplastic Drugs and Anti-infective Drugs Pegaspargase Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. Antineoplastic Drugs and Anti-infective Drugs Anti-Infective Drugs Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. Antineoplastic Drugs and Anti-infective Drugs PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. Antineoplastic Drugs and Anti-infective Drugs Bortezomib Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. Antineoplastic Drugs and Anti-infective Drugs Imatinib Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. Antineoplastic Drugs and Anti-infective Drugs Eltrombopag Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. Antineoplastic Drugs and Anti-infective Drugs dasatinib Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
- Primary Outcome Measures
Name Time Method change of plasma concentration of bortezomib 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
change of plasma concentration of eltrombopag 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
change of plasma concentration of imatinib 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
plasma concentration of anti-infective drug through study completion, an average of 14 days To detect the plasma concentrations of anti-infective drug after administration
change of plasma concentration of dasatinib 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
change of plasma concentration of pegaspargase 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, 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, China