Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT03844360
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'C520809', 'term': 'eltrombopag'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'D000069439', 'term': 'Dasatinib'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'C423652', 'term': 'pegylated granulocyte colony-stimulating factor'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of plasma concentration of bortezomib', 'timeFrame': 'at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration', 'description': 'To detect the plasma concentrations of bortezomib after administration'}, {'measure': 'change of plasma concentration of eltrombopag', 'timeFrame': 'at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration', 'description': 'To detect the plasma concentrations of eltrombopag after administration'}, {'measure': 'change of plasma concentration of imatinib', 'timeFrame': 'at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration', 'description': 'To detect the plasma concentrations of imatinib after administration'}, {'measure': 'change of plasma concentration of dasatinib', 'timeFrame': 'at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration', 'description': 'To detect the plasma concentrations of dasatinib after administration'}, {'measure': 'change of plasma concentration of pegaspargase', 'timeFrame': 'at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration', 'description': 'To detect the plasma concentrations of pegaspargase after administration'}, {'measure': 'plasma concentration of anti-infective drug', 'timeFrame': 'through study completion, an average of 14 days', 'description': 'To detect the plasma concentrations of anti-infective drug after administration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematological Neoplasms']}, 'referencesModule': {'references': [{'pmid': '38497347', 'type': 'DERIVED', 'citation': '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': '34240339', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be diagnosed with hematological neoplasms\n* Antineoplastic drugs or anti-infective drugs used as part of regular treatment\n\nExclusion Criteria:\n\n* expected survival time less than the treatment cycle;\n* patients with other factors that researcher considers unsuitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT03844360', 'briefTitle': 'Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease', 'orgStudyIdInfo': {'id': 'Antineoplastic Drugs001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antineoplastic Drugs and Anti-infective Drugs', 'description': 'Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.', 'interventionNames': ['Drug: Bortezomib', 'Drug: Eltrombopag', 'Drug: Imatinib', 'Drug: dasatinib', 'Drug: Pegaspargase', 'Drug: Anti-Infective Drugs', 'Drug: PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': "bortezomib was administered follow the doctor's advice.", 'armGroupLabels': ['Antineoplastic Drugs and Anti-infective Drugs']}, {'name': 'Eltrombopag', 'type': 'DRUG', 'otherNames': ['promacta'], 'description': "eltrombopag was administered follow the doctor's advice.", 'armGroupLabels': ['Antineoplastic Drugs and Anti-infective Drugs']}, {'name': 'Imatinib', 'type': 'DRUG', 'otherNames': ['Gleevec'], 'description': "imatinib was administered follow the doctor's advice.", 'armGroupLabels': ['Antineoplastic Drugs and Anti-infective Drugs']}, {'name': 'dasatinib', 'type': 'DRUG', 'otherNames': ['sprycel'], 'description': "dasatinib was administered follow the doctor's advice.", 'armGroupLabels': ['Antineoplastic Drugs and Anti-infective Drugs']}, {'name': 'Pegaspargase', 'type': 'DRUG', 'otherNames': ['Oncaspar'], 'description': "pegaspargase was administered follow the doctor's advice.", 'armGroupLabels': ['Antineoplastic Drugs and Anti-infective Drugs']}, {'name': 'Anti-Infective Drugs', 'type': 'DRUG', 'description': "anti-infective drugs was administered follow the doctor's advice.", 'armGroupLabels': ['Antineoplastic Drugs and Anti-infective Drugs']}, {'name': 'PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor', 'type': 'DRUG', 'otherNames': ['PEG-rhG-CSF'], 'description': "pegaspargase was administered follow the doctor's advice.", 'armGroupLabels': ['Antineoplastic Drugs and Anti-infective Drugs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'COMPLETED', 'country': 'China', 'facility': 'Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '300020', 'city': 'Tanjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': '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'}], 'centralContacts': [{'name': 'Wei Zhao, Ph.D', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '86053188383308'}, {'name': 'Yan H Shi, Ph.D', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '86053188383308'}], 'overallOfficials': [{'name': 'Wei Zhao, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Zhao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor; Head of department of clinical pharmacy and pharmacology', 'investigatorFullName': 'Wei Zhao', 'investigatorAffiliation': 'Shandong University'}}}}