NCT06319456招募中3 期
A Global Multicenter Open Label Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib vs Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 344
- 试验地点
- 15
- 主要终点
- Progress Free Survival (PFS)
研究概览
简要总结
This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL.
详细描述
The patients with newly diagnosed CLL/SLL, who have met all required eligibility criteria, will be randomized to the investigational group (Lisaftoclax in combination with Acalabrutinib) or the control group (immunochemotherapy, CIT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment.
- •With a measurable disease.
- •ECOG score 0-
- •QTcF interval: ≤450ms in males, ≤470ms in females.
- •Adequate bone marrow function independent of growth factor support.
- •Adequate liver, kidney and coagulation function.
- •Males and females of childbearing potential, and their partners voluntarily use effective contraceptive measures throughout the treatment and for at least three months after the last dose of the study drug. Male patients must avoid donation from the first dose of the study drug to three months after the last dose of the study drug.
- •Female patients of childbearing potential have negative serum pregnancy test results within 14 days prior to the first dose of the study drug.
- •Patients must be able to understand and voluntarily sign an informed consent form approved by the Ethics Committee (EC) before commencing any screening or study specific procedures.
- •Must be willing and able to complete research procedures and follow-up examinations.
排除标准
- •Any previous CLL specific treatment.
- •Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within 28 days prior to the first dose of the study drug or who receive a minor surgery (excluding biopsy) within 14 days prior to the initiation of the study.
- •Presence of significant cardiovascular disease within 6 months prior to study entry.
- •A history of significant kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease, which will have an adverse effect on the patient if he/she participates in the study, at the discretion of the investigator.
- •Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.
- •Known to have hypersensitivity to the drug ingredient or its analogues.
- •Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose.
- •Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry.
- •With a malabsorption syndrome or other conditions unsuitable for enteral administration.
- •Other clinically significant uncontrolled symptoms.
- •With primary active autoimmune disease and connective tissue disease.
- •Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.
结局指标
主要结局
Progress Free Survival (PFS)
时间窗: Up to 1 year
PFS is defined as the time from randomization to disease progression(PD) or death from any cause.
IRC-assessed PFS: The time from randomization to PD or death from any cause, whichever occurs first.
IRC-assessed PFS: The time from randomization to PD or death from any cause, whichever occurs first.
次要结局
- Objective Response Rate (ORR)(Up to 1 year)
- Minimal Residual Disease (MRD) negativity rate(Up to 1 year)
- Safety evaluation based on the adverse event concurrence(Up to 1 year)
- Key secondary endpoint: Investigator-assessed PFS: The time from randomization to PD or death from any cause, whichever occurs first.
- Other secondary endpoints: OS: The time from randomization to death.
- IRC- and investigator-assessed ORR: ORR includes complete response (CR), complete response with incomplete bone marrow recovery (CRi) or partial response (PR). CLL responsewill be assessed according to IWCLL NCI-WG guidelines (2018 Edition), and SLL response will be assessed according to Lugano 2014 criteria for response assessment in lymphoma.
- IRC- and investigator-assessed TTR: The interval from randomization to the date of the first confirmed CR, CRi, or PR.
- IRC- and investigator-assessed DOR: The interval from the date of first confirmed CR, CRi or PR to PD, or the start of a new anti-tumor treatment, or death, whichever occurs first.
- MRD negativity rate: Proportion of patients with MRD-negative result in bone marrow, peripheral blood, either or both.
- Safety and tolerability of patients: Treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
- Concentration data of Lisaftoclax and critical parameters of population pharmacokinetics.
研究者
研究点 (15)
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