A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA Study)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 136
- 主要终点
- PFS
研究概览
简要总结
This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors
详细描述
Approximately 440 patients will be enrolled, the patients who meet the eligibility criteria will be randomized in a 1:1 ratio to investigational arm (lisaftoclax in combination with a BTK inhibitor) or the control arm (BTK inhibitor alone). These patients with CLL/SLL have been on BTKi monotherapy and meet all other protocol required eligibility criteria.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months
- •ECOG Performance Status grade 0-2
- •Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:
- •Absolute neutrophil count ≥ 1.0 × 109/L
- •Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia
- •Total hemoglobin ≥ 9 g/dL,
- •Adequate renal function
- •Creatinine clearance must be > 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method.
- •For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is > 50 ml/min.
- •Adequate liver function as indicated by:
- •Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome
- •Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value
- •Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,
- •International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.
- •Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
排除标准
- 未提供
研究组 & 干预措施
Arm 2
mono therapy
干预措施: BTK inhibitor (Drug)
Arm 1
Combination therapy
干预措施: lisaftoclax +BTK inhibitor (Drug)
结局指标
主要结局
PFS
时间窗: 12 months
To evaluate the progression-free survival (PFS) of lisaftoclax in combination with BTKi compared with BTKi monotherapy in CLL/SLL patients previously treated with BTKi as determined by independent radiological review committee (IRC) using the iwCLL guidelines
次要结局
- overall survival(12 months)