Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 1:32 AM
Study NCT ID:
NCT04228393
Status:
UNKNOWN
Last Update Posted:
2020-01-14
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015122', 'term': 'Mercaptopurine'}], 'ancestors': [{'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2020-01-09', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'leukopenia', 'timeFrame': '6 weeks', 'description': 'Leukopenia was graded by common toxicity criteria as follows: Grade 3, 1.0-2.0 × 109/L, and Grade 4, \\< 1.0 × 109/L.'}, {'measure': 'thiopurine-induced leukopenia', 'timeFrame': '6-weeks', 'description': 'Resolution of leukopenia was determined after 6-MP dose reduction or discontinuation, both in the absence of other apparent causes for the leukopenia or its disappearance.'}], 'secondaryOutcomes': [{'measure': 'hepatotoxicity', 'timeFrame': '6 weeks', 'description': 'Hepatotoxicity was defined as aspartate aminotransferase (AST) or alanine transaminase (ALT) levels 2-fold above the upper limit without cytolysis.'}, {'measure': '6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes.', 'timeFrame': '3 months', 'description': 'Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.'}, {'measure': '6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes.', 'timeFrame': '3 months', 'description': 'Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute lymphoblastic leukemia', '6-mercaptopurine', 'children', 'individualized treatment'], 'conditions': ['Acute Lymphoblastic Leukemia, Pediatric']}, 'referencesModule': {'references': [{'pmid': '37753808', 'type': 'DERIVED', 'citation': 'Zhou Y, Wang L, Sun LR, Zhang L, Wang HM, Liu XT, Yang F, Wu KL, Liang YL, Zhao BB, Zhuang Y, Fu JQ, Song C, Li Y, Wang LZ, Xu HJ, Gu Y, van den Anker J, Ju XL, Zhu XF, Zhao W. Individualized Use of 6-Mercaptopurine in Chinese Children with ALL: A Multicenter Randomized Controlled Trial. Clin Pharmacol Ther. 2024 Feb;115(2):213-220. doi: 10.1002/cpt.3061. Epub 2023 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.', 'detailedDescription': 'To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed diagnosis of acute lymphoblastic leukemia;\n2. Age 1-18y at time of initial diagnosis;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n4. Informed consent signed by the patients parents or guardians before initiation of the study.\n\nExclusion Criteria:\n\n1. Ph-positive ALL, matrue B-cell ALL, BC-CML;\n2. Secondary to immunodeficiency, second cancer；\n3. Abnormal liver and kidney function;\n4. Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015;\n5. Patients who enrolled in another clinical trial;\n6. Expected survival time less than the treatment cycle;\n7. Patients with other factors that researcher considers unsuitable for inclusion'}, 'identificationModule': {'nctId': 'NCT04228393', 'briefTitle': 'The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China', 'orgStudyIdInfo': {'id': '2020-6-mercaptopurine-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment regimen', 'description': '6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.', 'interventionNames': ['Drug: 6-mercaptopurine', 'Procedure: Standard treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Individualized treatment regimen', 'description': '6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells.', 'interventionNames': ['Drug: 6-mercaptopurine', 'Procedure: Individualized treatment']}], 'interventions': [{'name': '6-mercaptopurine', 'type': 'DRUG', 'otherNames': ['6-MP'], 'description': '6-mercaptopurine was administered orally to patients once daily.', 'armGroupLabels': ['Individualized treatment regimen', 'Standard treatment regimen']}, {'name': 'Standard treatment', 'type': 'PROCEDURE', 'description': 'The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.', 'armGroupLabels': ['Standard treatment regimen']}, {'name': 'Individualized treatment', 'type': 'PROCEDURE', 'description': 'The initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells.', 'armGroupLabels': ['Individualized treatment regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tanjin', 'state': 'Tianjin Municipality', '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': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': "Children's Hospital of Hebei Province", 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor; Head of department of clinical pharmacy and pharmacology', 'investigatorFullName': 'Wei Zhao', 'investigatorAffiliation': 'Shandong University'}}}}