2024-516436-10-00招募中3 期
An international, 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)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- 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.
研究概览
简要总结
To assess the efficacy of APG-2575 combined with AZA versus placebo combined with AZA in the treatment of patients with newly diagnosed AML who are elderly or ineligible for standard induction chemotherapy (cytarabine and anthracyclines).
详细描述
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'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.
- •Life expectancy of ≥3 months.
- •Be able to accept oral administration.
- •Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and <70 years with ECOG score of 0-
- •Adequate kidney function.
- •White blood cell ≤ 30×10^9/L.
- •Adequate liver function.
- •Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.
- •Be able to understand and voluntarily sign written informed consent.
- •Patients must be willing and able to complete study procedures and follow-up examinations.
排除标准
- •The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.
- •Active leukemic infiltration of the central nervous system.
- •Active infection that is uncontrolled and requires systemic treatment.
- •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.
- •Previous treatment for hematologic disorders.
- •Patients who has a cardiovascular disability status of New York Heart Association Class >
- •Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.
- •Patients had a history of other malignancies prior to study initiation.
- •Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.
研究组 & 干预措施
APG-2575 (Lisaftoclax) combined with Azacitidine
Experimental
干预措施: APG-2575(Lisaftoclax ) (Drug)
APG-2575 (Lisaftoclax) combined with Azacitidine
Experimental
干预措施: Azacitidine Injection (Drug)
Placebo combined with Azacitidine
Active Comparator
干预措施: Placebo (Other)
Placebo combined with Azacitidine
Active Comparator
干预措施: Azacitidine Injection (Drug)
结局指标
主要结局
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.
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.
次要结局
- 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.
- Complete response (CR) rate: The proportion of patients with complete response in the total analysis population.
- Overall response rate (ORR): The proportion of patients who have achieved CR, CRi, CRh, MLFS and PR in total analysis population.
- Composite complete response (CRc) rate: The proportion of patients who have achieved CR, CRi and CRh in total analysis population.
- Time to response (TTR): The interval from the date of randomization to the date of the first CR, CRi, or CRh.
- 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.
- Safety and tolerability of subjects: Treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
- Population pharmacokinetic (Pop PK) parameters of APG-2575.
- Results of EORTC QLQ C30 (V3) and EuroQol 5-Dimension (EQ-5D) questionnaire.
研究者
Yifan Zhai, M.D., Ph.D.
Scientific
Ascentage Pharma Group Inc.
研究点 (6)
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