A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).
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
- •Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
- •Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
- •Presence of measurable disease
排除标准
- •Progression on prior BTK or PI3K delta inhibitor
- •Prior treatment with TGR-1202
- •Richter's transformation or CLL transformation to aggressive lymphoma
研究组 & 干预措施
Umbralisib
Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months.
干预措施: Umbralisib (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)
PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment.
次要结局
- Time to Treatment Failure (TTF)(From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months))
- Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)(From first dose of study treatment up to end of study (up to 61.7 months))
- Duration of Response (DOR)(From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months))
- Overall Response Rate (ORR)(Up to 61.7 months)