NCT07154264招募中2 期
A Phase 2 Study of DZD8586 Combination Therapy in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 22
- 主要终点
- Part A: Incidence of Adverse Events
研究概览
简要总结
This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL.
This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female ≥ 18 years of age.
- •ECOG performance status 0-2, and life expectancy ≥ 6 months.
- •Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
- •Patients with SLL must have at least one measurable lesion.
- •Adequate bone marrow reserve and organ functions.
- •Willing to comply with contraceptive restrictions.
排除标准
- •Any of previous or current treatment prohibited by protocol.
- •Any unresolved > grade 1 drug-related adverse events.
- •Known or suspected Richter's transformation, or prolymphocytic leukemia.
- •CNS involvement.
- •Active infection.
- •Any of severe cardiac or pulmonary abnormalities.
- •Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
- •Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
- •Prior malignancy within the past 3 years.
- •Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.
研究组 & 干预措施
Combination of DZD8586 and Venetoclax
Experimental
DZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
干预措施: Venetoclax (Drug)
Combination of DZD8586 and Venetoclax
Experimental
DZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.
干预措施: DZD8586 (Drug)
结局指标
主要结局
Part A: Incidence of Adverse Events
时间窗: 30 days after the last dose
Part B: 2-year progression free survival (PFS) rate assessed by investigator
时间窗: Approximately 5 years
次要结局
- Part B: Incidence of Adverse Events(30 days after the last dose)
- Part A: PFS assessed by investigator(Approximately 5 years)
- Part A: Objective response rate (ORR) assessed by investigator(Approximately 5 years)
- Part B: ORR assessed by investigator(Approximately 5 years)
研究者
研究点 (22)
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