NCT03370185撤回2 期
A Phase 2 Study of Duvelisib Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi)
SecuraBio8 个研究点 分布在 1 个国家开始时间: 2018年2月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 8
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.
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
- •≥ 18 years of age.
- •Diagnosis of CLL or SLL.
- •Received at least one prior anti-cancer therapy for CLL or SLL.
- •Previous exposure to BTKi and meet at least one of the criteria below:
- •Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
- •Discontinued a BTKi therapy due to BTKi treatment- related intolerance.
- •Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Resolution of toxicities due to prior BTKi therapy to acceptable level.
- •Willingness of male and female patients to use medically acceptable methods of birth control.
- •Willing and able to participate in all required study evaluations and procedures.
排除标准
- •Richter's transformation or prolymphocytic leukemia
- •Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- •Received prior transplant
- •Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K) inhibitor
- •Known central nervous system involvement by CLL/SLL
研究组 & 干预措施
Duvelisib
Experimental
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
干预措施: Duvelisib (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: From start of treatment to first documented response, 2 cycles (58 days)
次要结局
- Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks(Greater than or equal to 8 weeks)
- Treatment-Emergent adverse events (TEAEs) and changes in laboratory values(From start of treatment to end of treatment plus 30 days; 7 months)
- Progression-free survival (PFS), defined as the time from the first dose of study treatment to the first documentation of PD or death from any cause(Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months)
- Duration of response (DOR), defined as the time from the first documentation of response to the first documentation of PD or death due to any cause(Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months)
研究者
研究点 (8)
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