2024-517247-31-00招募中3 期
A Global Multicenter, Double-Blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination with Azacitidine (AZA) in Patients with Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 490
- 试验地点
- 2
- 主要终点
- xxx
研究概览
简要总结
To evaluate the efficacy of xxx
详细描述
This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Phase 3 Study of Lisaftoclax with Azacitidine in Myelodysplastic Syndrome
- 盲法
- Double (Subject, Investigator)
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
- •Newly diagnosed higher-risk MDS.
- •ECOG score of ≤
- •Expected survival ≥ 3 months.
- •Adequate organ function.
- •Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.
- •Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.
- •Subjects are able to complete study procedures and follow-up examinations.
排除标准
- •Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
- •Have undergone hematopoietic stem cell transplantation.
- •Uncontrolled active infection
- •Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
- •MDS or other conditions that cannot be administered enterally.
- •Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.
结局指标
主要结局
xxx
xxx
次要结局
- To evaluate the population pharmacokinetics (Pop PK) following treatment with xxx
- To compare the efficacy of xxx
- To evaluate the safety of xxx
- To evaluate Health Economics Outcomes Research (HEOR) measures of lisaftoclax xxx based on EuroQol 5 Dimension (EQ-5D).
研究者
Yifan Zhai
Scientific
Ascentage Pharma Group Inc.
研究点 (2)
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