A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 24
- 主要终点
- The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)
研究概览
简要总结
A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
详细描述
A Multicenter, Open-Label, Phase 2 study evaluating the efficacy and safety of Acalabrutinib in subjects with relapsed/refractory CLL (N=60) who are intolerant of ibrutinib therapy.
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
- •Men and women ≥ 18 years of age.
- •Prior diagnosis of CLL
- •Must have received ≥ 1 prior therapy for CLL
- •Intolerant of ibrutinib
- •Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria
- •Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- •ECOG performance status of ≤ 2.
排除标准
- •Ongoing AE attributed to ibrutinib therapy
- •Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
- •Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT- 199)
- •Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years.
- •Significant cardiovascular disease such as uncontrolled or symptomatic untreated arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- •Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor.
- •CNS involvement by CLL or related Richter's transformation.
- •Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection.
- •Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
- •History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug.
- •History of bleeding diathesis.
- •Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
- •Major surgical procedure within 28 days of first dose of study drug.
- •Requires treatment with a strong CYP3A inhibitor
研究组 & 干预措施
ACP-196 (acalabrutinib)
ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID
干预措施: ACP-196 (acalabrutinib) (Drug)
结局指标
主要结局
The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)
时间窗: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 4 years and 7 months). 1 cycle = 28 days
The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy. ORR is defined as the proportion of subjects achieving a best overall response (BOR) of either complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) at or before initiation of subsequent anticancer therapy. ORR will be analyzed per investigator's assessment.
次要结局
- Time-to-Next Treatment(From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years))
- Overall Survival(From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years).)
- Duration of Response(From the date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years))
- Progression-Free Survival(From the date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years).)