LISAFTOCLAX for Acute myeloid leukemia

Inclusion criteria

• {"criterion_text":"- Age ≥18 years."}
• {"criterion_text":"- Patient must be newly diagnosed with de novo AML based on WHO 2022 Acute Myeloid Leukemia (AML) criteria, and be ineligible for standard chemotherapy (cytarabine and anthracyclines) due to the age or concomitant illness. Elderly AML patient/AML patient intolerant to standard chemotherapy are defined as follows: (1) Age ≥ 70 years or (2) Age ≥ 18 years and < 70 years, and they must meet at least one of the following criteria: • ECOG Performance Status score of 2-3; • Cardiac history of congestive heart failure (CHF) requiring clinical treatment, ejection fraction ≤ 50% or chronic stable angina; • Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in one second (FEV1) ≤ 65%; (See Section 8.2.5) • 30 mL/min ≤ creatinine clearance < 45 mL/min • 1.5 × ULN < total bilirubin ≤ 3.0 × ULN • Other concomitant illnesses that prevent subjects from receiving standard chemotherapy, at the discretion of the investigator, must be reviewed and approved by the sponsor before study enrollment."}
• {"criterion_text":"- Life expectancy of ≥ 3 months."}
• {"criterion_text":"- Patient who is able to receive oral administration."}
• {"criterion_text":"- Patient aged ≥ 70 years with ECOG score of 0-2, or those aged ≥ 18 years and < 70 years with ECOG score of 0-3."}
• {"criterion_text":"- Creatinine clearance (CCr) must be ≥ 30 mL/min (calculated using Cockcroft–Gault formula)."}
• {"criterion_text":"- White blood cell (WBC) count ≤ 30 × 109/L (hydroxycarbamide is allowed to be used to reach this criterion)."}
• {"criterion_text":"- Liver function: Both ALT and AST ≤ 2.5 × ULN, and total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN for patients aged ≥ 18 years and < 70 years)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patient who is able to understand and voluntarily sign the written informed consent form before any study-specified procedures."}
• {"criterion_text":"- Patient must be willing and able to complete study procedures and follow-up examinations."}

Exclusion criteria

• {"criterion_text":"- Patient diagnosed with acute promyelocytic leukemia (FAB classification of AML-M3 or WHO classification of APL with PML-RAR α or t (9; 22) (q34.1; q11.2); BCR-ABL1-positive AML patients)."}
• {"criterion_text":"- Active leukemic infiltration of the central nervous system."}
• {"criterion_text":"- Active fungal/bacterial/viral infection requiring systemic treatment, including but not limited to HIV antibody positive, HCV antibody or RNA positive, HBsAg positive and HBV-DNA ≥ 2,000 copies/mL (or ≥ 500 IU/mL); those who are suffering from COVID-19 with serious clinical symptoms (subjects who receive injections with COVID-19 vaccine or other live-attenuated vaccines over 28 days before the first dose of the study drug can be enrolled)."}
• {"criterion_text":"- Use of moderate and/or strong CYP3A4 inducers and/or inhibitors within 7 days prior to the first dose of the study drug."}
• {"criterion_text":"- Patient who has been previously treated (including chemotherapy, targeted drugs, monoclonal antibodies and investigational drugs, excluding supportive treatments and hydroxycarbamide) for hematologic disorders, such as AML or MDS."}
• {"criterion_text":"- Patient who has a cardiovascular disability status of New York Heart Association (NYHA) Class > 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."}
• {"criterion_text":"- Subjects who have malabsorption syndrome or other conditions, making them unable to receive enteral administration or resulting in an impact on drug absorption."}
• {"criterion_text":"- Subjects who have 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 treated by other means) and clinically cured."}
• {"criterion_text":"- Any other condition or circumstance that would, at the discretion of the investigator, make the subject unsuitable for the study."}

Primary endpoints

• {"endpoint_text":"- Overall survival (OS): Interval between the date of randomization to the date of death of any cause. Survival time will be censored at the latest known survival date of the subject if death cannot be confirmed.","definition_or_measurement_approach":"Interval between the date of randomization to the date of death of any cause. Survival time will be censored at the latest known survival date of the subject if death cannot be confirmed."}

Secondary endpoints

• {"endpoint_text":"- Event-free survival (EFS): The interval from the date of randomization to the time point when any of the following “events” occur (whichever occurs first): • Progressive disease; • Disease recurrence after CR/CRi/CRh/MLFS; • Death of any cause (including but not limited to death caused by leukemia or therapeutic drugs); • CR/CRi/CRh/MLFS is not achieved after at least 6 treatment cycles.","definition_or_measurement_approach":"Interval from randomization to first event: progressive disease, disease recurrence after CR/CRi/CRh/MLFS, death from any cause, or failure to achieve CR/CRi/CRh/MLFS after ≥6 cycles."}
• {"endpoint_text":"- Complete response (CR) rate: The proportion of patients with complete response in the total analysis population.","definition_or_measurement_approach":"Proportion of patients achieving a complete response (CR) in the total analysis population."}
• {"endpoint_text":"- Overall response rate (ORR): The proportion of patients who have achieved CR, CRi, CRh, MLFS and PR in total analysis population.","definition_or_measurement_approach":"Proportion of patients achieving CR, CRi, CRh, MLFS or PR in total analysis population."}
• {"endpoint_text":"- Composite complete response (CRc) rate: The proportion of patients who have achieved CR, CRi and CRh in total analysis population.","definition_or_measurement_approach":"Proportion of patients achieving CR, CRi or CRh in the total analysis population."}
• {"endpoint_text":"- Time to response (TTR): The interval from the date of randomization to the date of the first CR, CRi, or CRh.","definition_or_measurement_approach":"Interval from randomization to date of first CR, CRi, or CRh."}
• {"endpoint_text":"- Duration of response (DOR): The interval from the date of confirming response (CR/CRi/CRh) to the date of disease recurrence or death of any cause (whichever occurs first). DOR will be calculated for patients with the best response of CR, CRh and CRi separately.","definition_or_measurement_approach":"Interval from confirmation of response to disease recurrence or death; calculated separately for CR, CRh and CRi responders."}
• {"endpoint_text":"- Safety and tolerability of subjects: Treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.","definition_or_measurement_approach":"Evaluation of TEAEs and TRAEs (treatment-emergent and treatment-related adverse events)."}
• {"endpoint_text":"- Population pharmacokinetic (Pop PK) parameters of APG-2575.","definition_or_measurement_approach":"Assessment of population pharmacokinetic parameters following APG-2575 administration."}
• {"endpoint_text":"- Results of EORTC QLQ C30 (V3) and EuroQol 5-Dimension (EQ-5D) questionnaire.","definition_or_measurement_approach":"Patient-reported quality of life assessed by EORTC QLQ-C30 (v3) and EQ-5D questionnaires."}

Italy

Earliest CTIS Part Ii Submission Date

20-03-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

368

Number Of Sites

6

Number Of Participants

16

Spain

Earliest CTIS Part Ii Submission Date

09-10-2025

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

166

Number Of Sites

2

Number Of Participants

24

Poland

Earliest CTIS Part Ii Submission Date

14-10-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

160

Number Of Sites

2

Number Of Participants

18

Primary sponsor

Full Name

Ascentage Pharma Group Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Hangzhou Tigermed Consulting Co. Ltd.

Responsibilities

sponsorDuties code: 6

Name

Iqvia Biotech Limited

Responsibilities

sponsorDuties codes: 1,12,2,5,8

Name

Almac Clinical Services Limited

Responsibilities

IP vendor (labeling, QP release and distribution)

Third parties

• {"country":"China","full_name":"Hangzhou Tigermed Consulting Co. Ltd.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Geneseeq Technology Inc","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Industry"}
• {"country":"United States","full_name":"Perceptive Informatics, LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Health care"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Dmed Biopharmaceutical Co. Ltd.","duties_or_roles":"Providing materials for IDMC","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Medidata","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Industry"}
• {"country":"United States","full_name":"Resolian Bioanalytics","duties_or_roles":"PK Analysis","organisation_type":"Industry"}
• {"country":"France","full_name":"Novasco","duties_or_roles":"Patient reimbursement","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 2, 5, 8","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"IP vendor (labeling, QP release and distribution)","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Nanjing Geneseeq Technology Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Industry"}