Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-22 @ 1:38 AM
Study NCT ID:
NCT04087967
Status:
UNKNOWN
Last Update Posted:
2019-09-12
First Post:
2019-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'D015255', 'term': 'Idarubicin'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2019-09-08', 'studyFirstSubmitQcDate': '2019-09-10', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Day 28-35 of induction course', 'description': 'ORR includes complete response (CR), CRi and PR. CR was defined as \\< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\\<5% bone marrow blasts, either ANC\\<1×10\\^9/L or platelets\\<100×10\\^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '3 years', 'description': 'time from randomization to death from any cause'}, {'measure': 'Leukemia-free survival (LFS)', 'timeFrame': '3 years', 'description': 'time from randomization to the first relapse or death'}, {'measure': 'Cumulative incidence of relapse(CIR)', 'timeFrame': '3 years', 'description': 'time from achievement of a remmission to the first relapse'}, {'measure': 'Number of adverse events', 'timeFrame': '2 years', 'description': 'adverse events are evaluated with CTCAE V5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decitabine', 'HAAG', 'AML'], 'conditions': ['Acute Myeloid Leukemia', 'Induction Chemotherapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients younger than 60 years.', 'detailedDescription': 'This is a phase 3, randomized, controlled, multi-center study in newly diagnosed AML patients younger than 60. The patients will be randomized to receive either DAC combined with HAAG or IA regimen in the induction treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.\n2. Age 18-59.\n3. ECOG score: 0-2.\n4. Treatment related or secondary AML.\n5. No history of previous chemotherapy or target therapy.\n6. Provide informed consent.\n\nExclusion Criteria:\n\n1. Patients are pregnant or lactating.\n2. Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.\n3. Patients with another malignant disease.\n4. Patients with uncontrolled active infection.\n5. Patients with left ventricular ejection fraction \\< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.\n6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \\> 3x upper limit of normal or bilirubin \\> 2.0 mg/dL.\n7. Patients with creatinine clearance rate \\< 50ml/min.\n8. Patients with active hepatitis B or hepatitis C infection.\n9. Patients with HIV infection.\n10. Patients with other commodities that the investigators considered not suitable for the enrollment.'}, 'identificationModule': {'nctId': 'NCT04087967', 'briefTitle': 'Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'A Phase 3, Randomized, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Newly Diagnosed Acute Myeloid Leukemia Patients Younger Than 60 Years', 'orgStudyIdInfo': {'id': 'DAC-HAAG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decitabine combined with HAAG', 'description': 'This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.', 'interventionNames': ['Drug: Decitabine plus HAAG regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IA Regimen', 'description': 'This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.', 'interventionNames': ['Drug: Idarubicine plus Cytarabine regimen']}], 'interventions': [{'name': 'Decitabine plus HAAG regimen', 'type': 'DRUG', 'description': 'Decitabine:20mg/m2/d,d1\\~5, intravenous infusion; Homoharringtonine:1mg/d,d3\\~16,intravenous infusion; Aclarubicin:10mg/d, d3\\~d10, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-16, subcutaneous injection;\n\nGranulocyte colony-stimulating factor (G-CSF):\n\n50-300μg/d (when WBC counts are less than 20×10\\^9/L ),subcutaneous injection;', 'armGroupLabels': ['Decitabine combined with HAAG']}, {'name': 'Idarubicine plus Cytarabine regimen', 'type': 'DRUG', 'description': 'Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion', 'armGroupLabels': ['IA Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaowen Tang, Ph.D.', 'role': 'CONTACT', 'email': 'xwtang1020@163.com', 'phone': '(0086)51267780086'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Xiaowen Tang, Ph.D.', 'role': 'CONTACT', 'email': 'xwtang1020@163.com', 'phone': '(0086)51267780086'}, {'name': 'Depei Wu, Ph.D.', 'role': 'CONTACT', 'email': 'drwudepei@163.com', 'phone': '(0086)51267780086'}], 'overallOfficials': [{'name': 'Xiaowen Tang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': "Changzhou No.2 People's Hospital", 'class': 'OTHER'}, {'name': "The First People's Hospital of Lianyungang", 'class': 'OTHER'}, {'name': "Jingjiang People's Hospital", 'class': 'OTHER'}, {'name': "Zhangjiagang First People's Hospital", 'class': 'OTHER'}, {'name': "The Second People's Hospital of Huai'an", 'class': 'OTHER'}, {'name': "The Third People's Hospital of Kunshan", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}