Health Condition 1: C929- Myeloid leukemia, unspecified
Conditions
Interventions
Intervention1: Lisaftoclax (APG-2575) in combination with Azacitidine: Lisaftoclax (APG-2575): QD, oral administration, every 28 days for a dosing cycle.
Azacitidine Injection: QD, subcutaneous or in
Sponsors
Ascentage Pharma Group Inc.
IQVIA RDS INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Patient will be eligible for the study if they meet each of the following criteria: 1. Age 18 years or more. 2. Patient must be newly diagnosed with de novo AML based on WHO 2022 Acute Myeloid Leukemia (AML) criteria, and be ineligible for standard chemotherapy. 3. Life expectancy of greater than or equal to 3 months. 4. Patient who is able to receive oral administration. 5. Patient aged greater than or equal to 70 years with ECOG score of 0-2, or those aged greater than or equal to 18 years and less than 70 years with ECOG score of 0-3. 6. Creatinine clearance (CCr) must be greater than or equal to 30 mL per min (calculated using Cockcroft Gault formula. See the Annex) 7. White blood cell (WBC) count less than or equal to 30 into 109 per L (hydroxycarbamide is allowed to be used to reach this criterion) 8. Liver function: Both ALT and AST less than or equal to 2.5 into ULN, and total bilirubin less than or equal to 1.5 into ULN (total bilirubin less than or equal to 3 into ULN for patients aged greater than or equal to 18 years and less than 70 years) 9. Males and females with childbearing potential (only postmenopausal women who have not menstruated for at least 12 months can be considered infertile) who agree to take effective contraceptive measures as confirmed by the investigator throughout the treatment period and at least 6 months after the last dose of the study drug. 10. Patient who is able to understand and voluntarily sign the written informed consent form before any study-specified procedures 11. Patient must be willing and able to complete study procedures and follow-up examinations
Exclusion criteria
Exclusion criteria: Patient who meet any of the following exclusion criteria are not eligible for this study: 1. Patient diagnosed with acute promyelocytic leukemia [FAB classification of AML-M3 or WHO classification of acute promyelocytic leukemia (APL) with PML-RAR alpha] or t (9, 22) (q34.1, q11.2), BCR-ABL1-positive AML. 2. Active leukemic infiltration of the central nervous system. 3. Active fungal or bacterial or viral infection requiring systemic treatment. 4. Use of moderate and or strong CYP3A4 inducers and or inhibitors within 7 days prior to the first dose of the study drug. 5. Patient who has been previously treatedfor hematologic disorders, such as AML or myelodysplastic syndrome (MDS). 6. Patient who has a cardiovascular disability status of New York Heart Association (NYHA) Class more than 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest, but ordinary physical activity results in fatigue, palpitation, dyspnea or angina pectoris. 7. Patient who has malabsorption syndrome or other conditions, making them unable to receive enteral administration or resulting in an impact on drug absorption. 8. Patient who has a history of other malignancies before the start of the study, with the exception of: Cervical carcinoma in situ or breast cancer in situ after adequate treatment; Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Previous malignancies that are not spread, surgically resected (or by other means) and clinically cured. 9. Any other condition or circumstance that would, at the discretion of the investigator, make the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival: The primary endpoint was overall survival, defined as the time from the date of randomization to the date of death of any cause.Timepoint: Upto 5 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Objective Response Rate (ORR): ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.Timepoint: Up to 5 years;Safety evaluation based on the adverse event concurrence: Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.Timepoint: Up to 5 years | — |
Countries
Australia, China, Czech Republic, France, India, Italy, Poland, Russian Federation, Spain
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed