Acalabrutinib 单独或联合治疗 B 细胞非霍奇金淋巴瘤患者的研究
Acalabrutinib 单独或联合治疗 B 细胞非霍奇金淋巴瘤患者的开放标签 1b/2 期研究
Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.
Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.
Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL
研究概览
详细说明
An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Alberta
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Edmonton、Alberta、加拿大、t6G1Z2
- Research Site
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Ontario
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London、Ontario、加拿大、N6A 5W9
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Toronto、Ontario、加拿大、M5G 2M9
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Bologna、意大利、40138
- Research Site
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Milan、意大利、20132
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Palermo、意大利、90146
- Research Site
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Arizona
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Tucson、Arizona、美国、85719
- Research Site
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California
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Downey、California、美国、90241
- Research Site
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Duarte、California、美国、91010
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Fountain Valley、California、美国、92708
- Research Site
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Santa Monica、California、美国、90404
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Florida
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Coral Gables FL、Florida、美国、33146
- Research Site
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Illinois
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Chicago、Illinois、美国、60612
- Research Site
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Chicago、Illinois、美国、60637
- Research Site
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Chicago、Illinois、美国、60611
- Research Site
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Kentucky
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Louisville、Kentucky、美国、40207
- Research Site
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Louisiana
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New Orleans、Louisiana、美国、70112
- Research Site
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Michigan
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Ann Arbor、Michigan、美国、48109
- Research Site
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New Jersey
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Morristown、New Jersey、美国、07960
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New York
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Lake Success、New York、美国、11042
- Research Site
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New York、New York、美国、10021
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Ohio
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Columbus、Ohio、美国、43210
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South Carolina
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Greenville、South Carolina、美国、29615
- Research Site
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Texas
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Dallas、Texas、美国、75235
- Research Site
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Houston、Texas、美国、77030
- Research Site
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San Antonio、Texas、美国、78217
- Research Site
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Temple、Texas、美国、76508
- Research Site
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Utah
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Salt Lake City、Utah、美国、84112
- Research Site
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Washington
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Spokane、Washington、美国、99208
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women ≥ 18 years of age.
- Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL, or subjects who have not previously received systemic anticancer therapy for FL., and which requires treatment.
- Part 2: For subject with relapsed or refractory MZL:
Histologically confirmed MZL including splenic, nodal, and extranodal sub-types
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Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4;
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Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be Helicobacter pylori (HP)-negative
- Part 3: For subjects with FL: Pathologically confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL and which requires treatment per National Cancer Institute or ESMO clinical practice guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Exclusion Criteria:
- •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
- Significant cardiovascular disease such as uncontrolled or symptomatic 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
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
- Breast feeding or pregnant
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Part 1: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects |
其他名称：
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实验性的：Part 1: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects |
其他名称：
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实验性的：Part 2: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects |
其他名称：
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实验性的：Part 2: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects |
其他名称：
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实验性的：Part 3: acalabrutinib Regimen 1
acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects |
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Part 1: Incidence of Treatment-emergent Adverse Events.
大体时间：From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
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Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL). |
From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
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Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
大体时间：Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).
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The objective response rate (ORR) is used to characterize the activity of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL). |
Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).
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Part 3: Incidence of Treatment-emergent Adverse Events.
大体时间：From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).
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Treatment-emergent adverse events were used to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in participants with relapsed/refractory follicular lymphoma (R/R FL). |
From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).
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合作者和调查者
合作者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ACE-LY-003
- 2023-509350-63-00 (注册表标识符：CTIS (EU))
- 2019-000111-84 (EudraCT编号)
- 2023 (美国 NIH 拨款/合同)
- 2019 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.