Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-30 @ 5:11 AM
Study NCT ID:
NCT06451861
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'C579720', 'term': 'venetoclax'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'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': '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'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite complete remission (CRc)', 'timeFrame': '2 months', 'description': 'composite complete remission，CRc: CR + CRi + MLFS'}], 'secondaryOutcomes': [{'measure': 'the rate of MRD turn negative', 'timeFrame': '6 months', 'description': 'minimal residual disease turn negative'}, {'measure': 'DoR', 'timeFrame': '2 year', 'description': 'Duration of remission'}, {'measure': 'RFS', 'timeFrame': '1 year', 'description': 'Relapsed-free survival'}, {'measure': 'OS', 'timeFrame': '1 year', 'description': 'Overall survival'}, {'measure': 'AE', 'timeFrame': 'Throughout the study until the end, up to 2 years', 'description': 'Incidence of of grade 3-4 adverse events/Duration of severe myelosuppression/ Incidence of severe infection/Treatment-related mortality, according to Common Terminology Criteria for Adverse Events, versions 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ABC-14 regimen', '"3+7" regimen', 'AB-14 regimen'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '41366419', 'type': 'DERIVED', 'citation': 'Yan H, Huang X, Wu P, Deng C, Li M, Lai P, Du X, Weng J. Comparing the efficacy and safety of the ABC-14 regimen (azacitidine, venetoclax, and chidamide) with traditional "3 + 7" intensive induction regimen or AB-14 regimen (venetoclax combined with azacitidine) in newly diagnosed AML: study protocol for a prospective, multicenter, randomized, open-label clinical trial. Trials. 2025 Dec 10. doi: 10.1186/s13063-025-09339-y. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia', 'detailedDescription': 'Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients \\<60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments);\n2. Age ≥18 years old;\n3. ECOG≤4;\n4. The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.\n\nExclusion Criteria:\n\n1. Known history of allergy to the investigational drug;\n2. Resistance to azacytidine, azacitidine, Venetoclax;\n3. Inability to take oral medication;\n4. Combined with uncontrolled active infections (including bacterial, fungal or viral infections);\n5. Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;\n6. Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06451861', 'briefTitle': 'Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'ABC-14_101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABC-14 regimen', 'description': 'AZA,Venetoclax,Chidamide', 'interventionNames': ['Drug: Chidamide', 'Drug: Venetoclax', 'Drug: azacitidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3+7 chemotherapy regimen', 'description': 'Daunorubicin/idarubicin/mitoxantrone and cytarabine', 'interventionNames': ['Drug: Anthracyclines or anthraquinones', 'Drug: cytarabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AB-14 regimen', 'description': 'AZA,Venetoclax', 'interventionNames': ['Drug: Venetoclax', 'Drug: azacitidine']}], 'interventions': [{'name': 'Chidamide', 'type': 'DRUG', 'description': 'Induction Therapy', 'armGroupLabels': ['ABC-14 regimen']}, {'name': 'Venetoclax', 'type': 'DRUG', 'description': 'Induction Therapy', 'armGroupLabels': ['AB-14 regimen', 'ABC-14 regimen']}, {'name': 'azacitidine', 'type': 'DRUG', 'description': 'Induction Therapy', 'armGroupLabels': ['AB-14 regimen', 'ABC-14 regimen']}, {'name': 'Anthracyclines or anthraquinones', 'type': 'DRUG', 'otherNames': ['idarubicin', 'daunorubicin', 'mitoxantrone'], 'description': 'Induction Therapy', 'armGroupLabels': ['3+7 chemotherapy regimen']}, {'name': 'cytarabine', 'type': 'DRUG', 'description': 'Induction Therapy', 'armGroupLabels': ['3+7 chemotherapy regimen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dongguan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yirong Jiang', 'role': 'CONTACT'}], 'facility': 'Dongguan General Hosptial', 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'city': 'Foshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Zhao', 'role': 'CONTACT'}], 'facility': "Foshan First People's Hospital", 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Du', 'role': 'CONTACT'}, {'name': 'Jianyu WENG', 'role': 'CONTACT'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yang Liang', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Runhui Zheng', 'role': 'CONTACT'}], 'facility': 'The Fifth Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xueyi Pan', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Guangdong Pharmaceutical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenqian Huang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liye Zhong', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xu Ye', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xin Du', 'role': 'CONTACT'}], 'facility': "Shenzhen second people's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Zhanjiang', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuming ZHANG', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Guangdong Medical University', 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'city': 'Zhuhai', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaoliang Li', 'role': 'CONTACT'}], 'facility': 'Zhuhai General Hosptial', 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}, {'city': 'Haikou', 'state': 'Hainan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': "Li'e Lin", 'role': 'CONTACT'}], 'facility': 'Hainan General Hosptial', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}], 'centralContacts': [{'name': 'Jianyu Weng', 'role': 'CONTACT', 'email': 'wengjianyu@gdph.org.cn', 'phone': '020-83827812'}, {'name': 'Du Xin', 'role': 'CONTACT', 'email': 'xind@gdph.org.cn', 'phone': '020-83827812'}], 'overallOfficials': [{'name': 'Jianyu Weng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Provincial People Hosptial'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}