A Phase 3, Randomized, Double-Blind Study Comparing Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab (BR), With Placebo and BR for the Treatment of Newly Diagnosed Mantle Cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male and female participants aged 18 years or older. (Japan aged 20 years or older.)
- •Have received no previous systemic anti-lymphoma therapies.
- •Pathologically confirmed MCL by local laboratory.
- •Histologically confirmed CD20 expression (by flow cytometry or immunohistochemistry) of the MCL cells as assessed by pathology.
- •Ineligible for high-dose chemotherapy and autologous stem cell transplantation.
- •Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
- •ECOG PS of 0 to
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Presence of any lymphoma other than MCL.
- •Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
- •Requires treatment with potent inducers and inhibitors of CYP3A4
- •Inadequate organ functions including hematopoiesis, liver, and kidney significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
- •History of other malignancy within 2 years of study entry.
- •Known HIV infection, HBV or HCV.
- •HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participant's positive for HCV antibody will be eligible if they are negative for HCV-RNA.
- •Clinically significant cardiac disease, congestive heart failure, including unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months of randomization.
- •Abnormal ECG findings that are clinically meaningful per investigator's assessment.
- •Women who are pregnant or breastfeeding
- •Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
研究组 & 干预措施
Treatment Group A
Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.
干预措施: parsaclisib (Drug)
Treatment Group A
Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.
干预措施: rituximab (Drug)
Treatment Group A
Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.
干预措施: bendamustine (Drug)
Treatment group B
Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.
干预措施: rituximab (Drug)
Treatment group B
Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.
干预措施: bendamustine (Drug)
Treatment group B
Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 7 years
Defined as the time from the date of randomization until the date of first-documented disease progression, as determined by an Independent Review Committee (IRC) based on the Lugano criteria, or death from any cause, whichever happens first.
次要结局
- Disease Control Rate(7 Years)
- Complete Response Rate(7 Years)
- Time To Next anti-Lymphoma Treatment(7 Years)
- Duration of Response(7 Years)
- Duration Of Complete Response(7 Years)
- Overall Survival(10 years)
- Event Free Survival(7 Years)
- Progression-Free Survival on next anti-lymphoma treatment(7 Years)
- Objective Response Rate(7 Years)
- Treatment Emergent Adverse Events(7 Years)