Phase I/II Multi-site Study Evaluating the MTD, Safety and Efficacy of the Combination Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
研究概览
简要总结
The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).
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
- •Age ≥18 years
- •Diagnosis of mantle cell lymphoma (MCL) established by histologic assessment
- •Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL
- •ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to 2
- •All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program
- •Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- •Men and Women of childbearing potential on appropriate contraception
- •Adequate organ function
- •Ability to understand and the willingness to sign a written informed consent.
- •Ability to swallow oral capsules/tablets
排除标准
- •Prior treatment for MCL with chemotherapy
- •Pregnant or breastfeeding women
- •Grade 2 or higher peripheral neuropathy
- •Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment
- •Significant cardiovascular disease
- •Any condition that might significantly impair drug absorption as determined by the investigator
- •Uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug
- •History of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug
- •Concurrent participation in another clinical trial
- •Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 week prior to treatment initiation.
- •Psychiatric illness or social situations that would limit compliance with study requirements
- •Subject has known positivity to HIV
- •Active infection with Hepatitis B or C virus as determined by a detectable viral load on PCR.
- •Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to< 2 years.
研究组 & 干预措施
Venetoclax, Lenalidomide, Rituximab
Rituximab 375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12 Lenalidomide 10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12. Venetoclax PO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.
干预措施: Venetoclax (Drug)
Venetoclax, Lenalidomide, Rituximab
Rituximab 375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12 Lenalidomide 10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12. Venetoclax PO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.
干预措施: Lenalidomide (Drug)
Venetoclax, Lenalidomide, Rituximab
Rituximab 375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12 Lenalidomide 10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12. Venetoclax PO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.
干预措施: Rituximab (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
时间窗: 42 Days
次要结局
- The proportion of patients with a Complete Response (CR)(Up to 4 Years)
- The proportion of patients that respond to treatment(Up to 4 Years)