CTRI/2026/03/105871尚未招募3 期
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)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 486
- 试验地点
- 14
- 主要终点
- 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.
研究概览
简要总结
This is a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 pivotal registrational study, which is designed to assess the overall survival (OS) of APG-2575 (Lisaftoclax) combined with AZA versus placebo combined with AZA in patients with newly diagnosed AML who are elderly or ineligible for standard induction chemotherapy.
Subjects will be randomized to either of the following two groups in a ratio of 1:1 after completing screening procedure and being confirmed eligible:
§ Investigational drug group: APG-2575 combined with AZA: APG-2575, oral, once a day (QD) for 28 consecutive days (D1-D28). Azacitidine (AZA) will be administered daily as 75 mg/m2/d by intravenous (IV) infusion or subcutaneously (SC), ideally, on cycle days 1-7, OR on cycle days 1-5 and 8-9 in a 28-day cycle.
§ Control group: Placebo combined with AZA: placebo, oral, once a day (QD) for 28 consecutive days (D1-D28). Azacitidine (AZA) will be administered daily as 75 mg/m2/d by intravenous (IV) infusion or subcutaneously (SC), ideally, on cycle days 1-7, OR on cycle days 1-5 and 8-9in a 28-day cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient will be eligible for the study if they meet each of the following criteria:
- •Age 18 years or more.
- •Patient must be newly diagnosed with de novo AML based on WHO 2022 Acute Myeloid Leukemia (AML) criteria, and be ineligible for standard chemotherapy.
- •Life expectancy of greater than or equal to 3 months.
- •Patient who is able to receive oral administration.
- •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-
- •Creatinine clearance (CCr) must be greater than or equal to 30 mL per min (calculated using Cockcroft–Gault formula.
- •See the Annex)
- •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)
- •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)
- •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.
- •Patient who is able to understand and voluntarily sign the written informed consent form before any study-specified procedures
- •Patient must be willing and able to complete study procedures and follow-up examinations.
排除标准
- •Patient who meet any of the following exclusion criteria are not eligible for this study:
- •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.
- •Active leukemic infiltration of the central nervous system.
- •Active fungal or bacterial or viral infection requiring systemic treatment.
- •Use of moderate and or strong CYP3A4 inducers and or inhibitors within 7 days prior to the first dose of the study drug.
- •Patient who has been previously treatedfor hematologic disorders, such as AML or myelodysplastic syndrome (MDS).
- •Patient who has a cardiovascular disability status of New York Heart Association (NYHA) Class more than
- •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.
- •Patient who has malabsorption syndrome or other conditions, making them unable to receive enteral administration or resulting in an impact on drug absorption.
- •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.
- •Any other condition or circumstance that would, at the discretion of the investigator, make the subject unsuitable for the study.
结局指标
主要结局
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.
时间窗: Upto 5 Years
次要结局
- 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.(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.(Up to 5 years)
研究者
研究点 (14)
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