An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 主要终点
- Overall Response Rate
研究概览
简要总结
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
详细描述
This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.
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
- •Documentation of del (17p13.1)
- •Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
- •Measurable nodal disease by computed tomography (CT)
排除标准
- •History or current evidence of Richter's transformation or prolymphocytic leukemia
- •Prior hematologic stem cell transplantation <6 months from study enrollment or any ongoing GVHD
- •Prior exposure to ibrutinib
研究组 & 干预措施
ibrutinib
All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (AEs)(From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure)