A Phase 2 Single-Arm, Open-Label Study to Assess the Safety and Efficacy of Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - The CORAL Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- To determine the uMRD rate in PB and BM by flow cytometry
研究概览
简要总结
A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL.
详细描述
This is an open label Phase 2 clinical study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with R/R CLL.
VEN and R will be administered per standard of care.
Subjects must have histologically confirmed relapsed/refractory CLL and received ≥1 lines of prior therapy
A total 42 subjects will be enrolled and treated with zandelisib in combination with VEN + R.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Males or females ≥18 years
- •Histologically confirmed relapsed/refractory CLL who received ≥1 lines of prior therapy
- •At least one bi-dimensionally measurable nodal lesion >1.5 cm
- •Adequate renal, hepatic function
- •Adequate hematologic parameters at screening
排除标准
- •Subjects who relapsed or progressed on BCL-2 inhibitor
- •Relapsed within 2 years of discontinuation of prior PI3K inhibitor (PI3Ki) therapy or disease progression on PI3Ki therapy
- •History or currently active HBV, HCV; any uncontrolled active infection, HIV infection; HIV-related lymphoma
- •History of Richter's transformation or prolymphocytic leukemia
- •Known allergies to both xanthine oxidase inhibitors and rasburicase, or any excipients of the drug products
- •Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure
- •Pregnant women
研究组 & 干预措施
Cohort A
Ven "low dose" + Rituximab + Zandelisib
干预措施: Zandelisib (Drug)
Cohort A
Ven "low dose" + Rituximab + Zandelisib
干预措施: Rituximab (Drug)
Cohort A
Ven "low dose" + Rituximab + Zandelisib
干预措施: Venetoclax (Drug)
Cohort B
Ven "standard dose" + Rituximab + Zandelisib
干预措施: Zandelisib (Drug)
Cohort B
Ven "standard dose" + Rituximab + Zandelisib
干预措施: Rituximab (Drug)
Cohort B
Ven "standard dose" + Rituximab + Zandelisib
干预措施: Venetoclax (Drug)
结局指标
主要结局
To determine the uMRD rate in PB and BM by flow cytometry
时间窗: 2 year
measured by 8-color flow cytometry with a quantitative lower limit of detection of at least 10-4 (1 in 10,000 cells).
次要结局
- Progression Free Survival(5 years)
- ORR(2 years)