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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antineoplastic Drugs and Anti-infective Drugs | Experimental | Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | bortezomib was administered follow the doctor's advice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhao, Ph.D | Contact | 86053188383308 | zhao4wei2@hotmail.com | |
| Yan H Shi, Ph.D | Contact | 86053188383308 | zhao4wei2@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao, Ph.D | Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University | Completed | Xuzhou | Jiangsu | 221000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38497347 | Derived | 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. | |
| 34240339 |
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| Eltrombopag | Drug | eltrombopag was administered follow the doctor's advice. |
|
|
| Imatinib | Drug | imatinib was administered follow the doctor's advice. |
|
|
| dasatinib | Drug | dasatinib was administered follow the doctor's advice. |
|
|
| Pegaspargase | Drug | pegaspargase was administered follow the doctor's advice. |
|
|
| Anti-Infective Drugs | Drug | anti-infective drugs was administered follow the doctor's advice. |
|
| PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor | Drug | pegaspargase was administered follow the doctor's advice. |
|
|
| 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 | Recruiting | Tanjin | Tianjin Municipality | 300020 | China |
| 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. |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| C520809 | eltrombopag |
| D000068877 | Imatinib Mesylate |
| D000069439 | Dasatinib |
| C042705 | pegaspargase |
| D000890 | Anti-Infective Agents |
| C423652 | pegylated granulocyte colony-stimulating factor |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D011743 | Pyrimidines |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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