An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 主要终点
- Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
研究概览
简要总结
This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.
详细描述
The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 + CVP, but could continue to receive maintenance therapy with MabThera™ (rituximab) per standard of care.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MK-8808 Combination Therapy
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
干预措施: MK-8808 (Drug)
MK-8808 Combination Therapy
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
干预措施: cyclophosphamide (Drug)
MK-8808 Combination Therapy
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
干预措施: vincristine (Drug)
MK-8808 Combination Therapy
Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
干预措施: prednisolone (Drug)
结局指标
主要结局
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
时间窗: From first dose of combination therapy up to 24 weeks
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy
时间窗: From first dose of single agent MK-8808 up to 2 years
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
次要结局
- Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy(Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years))
- Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP(Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks))
- Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP(Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks))
- Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance(Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years))
- Clinical Response of Tumor to MK-8808/CVP Combination Therapy(Up to 2 years)