Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-02 @ 2:27 AM
Study NCT ID:
NCT04373395
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-12', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission (CR) rate', 'timeFrame': 'Complete blood count recovery or 1 month after 1 course of D-CLAG regimen', 'description': 'Complete remission rate after 1 course of D-CLAG regimen'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute myeloid leukemia (non-acute promyelocytic leukemia) must be diagnosed before enrollment. Diagnostic criteria refer to WHO (World Health Organization) classification.\n* Refractory or relapsed AML: refractory is defined as the failure of CR after 2 courses of standard induced remission therapy (2 courses of idarubicin+cytarabine (IA) regimen or 1 course of IA regimen + 1 course of high dose cytarabine); Relapse is defined as the blast cells \\>5% in bone marrow or presence of extramedullary leukemia for patient who achieved CR before.\n* Age 18-70.\n* Eastern cancer cooperation group (ECOG) ≤2.\n* Creatinine clearance ≥30 mL/min (estimated glomerular filtration rate (eGFR) according to the Cockcroft-Gault formula or Modification of Diet in Renal Disease (MDRD) formula).\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.\n* Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50%.\n* Life expectancy \\>8 weeks.\n* Voluntarily sign the informed consent and understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* White blood cell (WBC) \\> 50 \\* 109 / L\n* Patients who have received salvage treatment with D-CLAG.\n* Current active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the New York heart association (NYHA) functional classification, or a history of myocardial infarction within 6 months prior to screening.\n* Other serious diseases that may limit patient participation in the trial (e.g. progressive infections, uncontrolled diabetes).\n* Pregnant or nursing women.\n* Unable to understand or follow the research protocol or unable to sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT04373395', 'briefTitle': 'Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'A Prospective, Single-arm, Multicenter, Exploratory Study to Evaluate the Efficacy and Safety of D-CLAG Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'D-CLAG-ZJU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-CLAG', 'description': 'Administration of D-CLAG regimen (Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor)', 'interventionNames': ['Procedure: D-CLAG']}], 'interventions': [{'name': 'D-CLAG', 'type': 'PROCEDURE', 'description': 'Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor', 'armGroupLabels': ['D-CLAG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongxian Hu, Dr', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '15957162012'}], 'facility': 'the First Affiliated Hospital,School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yongxian Hu', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '+86-0571-87236476'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, {'name': 'Zhejiang Provincial Tongde Hospital', 'class': 'OTHER'}, {'name': 'Jinhua Central Hospital', 'class': 'OTHER'}, {'name': 'Huizhou Municipal Central Hospital', 'class': 'OTHER'}, {'name': 'The Sixth Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Hanhui Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President of The First Affiliated Hospital, College of Medicine, Zhejiang University', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}