Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-27 @ 12:22 PM
Study NCT ID:
NCT06389292
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
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': 'C000726452', 'term': 'Lisaftoclax'}, {'id': 'D001374', 'term': 'Azacitidine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 486}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-03-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival（OS）', 'timeFrame': 'Up to 5 years', 'description': 'The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with Objective Response Rate (ORR)', 'timeFrame': 'Up to 5 years', 'description': 'ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.'}, {'measure': 'Safety evaluation based on the adverse event concurrence', 'timeFrame': 'Up to 5 years', 'description': 'Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['APG -2575', 'Lisaftoclax'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'A global, multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.', 'detailedDescription': "The newly diagnosed acute myeloid leukemia, who are not eligible for standard induction chemotherapy, will be randomized to the investigational group 'Lisaftoclax (APG-2575) + AZA' or the control group 'placebo+ AZA'."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.\n2. Life expectancy of ≥3 months.\n3. Be able to accept oral administration.\n4. Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and \\<70 years with ECOG score of 0-3.\n5. Adequate kidney function.\n6. White blood cell ≤ 30×10\\^9/L.\n7. Adequate liver function.\n8. Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.\n9. Be able to understand and voluntarily sign written informed consent.\n10. Patients must be willing and able to complete study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.\n2. Active leukemic infiltration of the central nervous system.\n3. Active infection that is uncontrolled and requires systemic treatment.\n4. Use of strong inducers of CYP3A4 within 7 days prior to the first dose of the investigational drug, and/or use of moderate to strong inhibitors of CYP3A4 within 7 days or 3-5 half-lives (whichever is longer) prior to the first dose of the investigational drug.\n5. Previous treatment for hematologic disorders.\n6. Patients who has a cardiovascular disability status of New York Heart Association Class \\> 2.\n7. Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.\n8. Patients had a history of other malignancies prior to study initiation.\n9. Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06389292', 'briefTitle': 'A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascentage Pharma Group Inc.'}, 'officialTitle': 'A Global, Multicenter, Randomized, Double-blind, Phase 3 Pivotal Registrational Clinical Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (GLORA-3)', 'orgStudyIdInfo': {'id': 'APG2575AG301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APG-2575 (Lisaftoclax) combined with Azacitidine', 'interventionNames': ['Drug: APG-2575(Lisaftoclax )', 'Drug: Azacitidine Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo combined with Azacitidine', 'interventionNames': ['Other: Placebo', 'Drug: Azacitidine Injection']}], 'interventions': [{'name': 'APG-2575(Lisaftoclax )', 'type': 'DRUG', 'description': 'QD, oral administration, every 28 days for a dosing cycle.', 'armGroupLabels': ['APG-2575 (Lisaftoclax) combined with Azacitidine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'QD, oral administration, every 28 days for a dosing cycle.', 'armGroupLabels': ['Placebo combined with Azacitidine']}, {'name': 'Azacitidine Injection', 'type': 'DRUG', 'description': 'QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.', 'armGroupLabels': ['APG-2575 (Lisaftoclax) combined with Azacitidine', 'Placebo combined with Azacitidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Wei, M.D.', 'role': 'CONTACT', 'email': 'weihui@ihcams.ac.cn', 'phone': '022-23909120'}, {'name': 'Hui Wei, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hematology Hospital of the Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Jin, M.D.', 'role': 'CONTACT', 'email': 'jiej0503@163.com'}, {'role': 'CONTACT', 'phone': '0571-87236896'}, {'name': 'Jie Jin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '108814', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Natalia CHERNOVA, Dr.Med.Sci', 'role': 'CONTACT', 'email': '79166602763@mail.ru', 'phone': '7-916-660-27-63'}, {'name': 'Natalia CHERNOVA, Dr.Med.Sci', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Moscow Multidisciplinary Clinical Center "Kommunarka"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125284', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Vadim DORONIN, MD', 'role': 'CONTACT', 'email': 'vadim_doronin@mail.ru', 'phone': '7-926-270-83-45'}, {'name': 'Vadim DORONIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Botkin Moscow Multidisciplinary Research and Clinical Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '191024', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexey KUVSHINOV, Ph.D.', 'role': 'CONTACT', 'email': 'xupypr83@mail.ru', 'phone': '7-921-370-88-46'}, {'name': 'Alexey KUVSHINOV, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194291', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sergey VOLOSHIN, Ph.D.', 'role': 'CONTACT', 'email': 'servolos@gmail.com', 'phone': '7-921-955-07-49'}, {'name': 'Sergey VOLOSHIN, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Leningrad Regional Clinical Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Yifan Zhai, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'yzhai@ascentage.com', 'phone': '+86-20-28068501'}, {'name': 'Lihui Liu, M.D.', 'role': 'CONTACT', 'email': 'Lihui.Liu@ascentage.com'}], 'overallOfficials': [{'name': 'Jianxiang Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hematology Hospital of the Chinese Academy of Medical Sciences'}, {'name': 'Jie Jin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascentage Pharma Group Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}