Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Determine Acceptable Adverse Events That Are Related to Treatment
研究概览
简要总结
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia, or Non-Hodgkin's Lymphoma
- •Refractory to or relapsed after at least 1 prior treatment regimen
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
排除标准
- •Any major surgery, chemotherapy or immunotherapy within the last 21 days
- •Known hepatitis B virus, hepatitis C virus or HIV infection
- •Known histological transformation from CLL to an aggressive lymphoma (Richter's)
研究组 & 干预措施
Ublituximab + Umbralisib + Venetoclax
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
干预措施: Venetoclax (Drug)
Ublituximab + Umbralisib + Venetoclax
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
干预措施: Umbralisib (Drug)
Ublituximab + Umbralisib + Venetoclax
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose
干预措施: Ublituximab (Biological)
Ublituximab + Umbralisib + Lenalidomide
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
干预措施: Umbralisib (Drug)
Ublituximab + Umbralisib + Lenalidomide
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
干预措施: Ublituximab (Biological)
Ublituximab + Umbralisib + Lenalidomide
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Determine Acceptable Adverse Events That Are Related to Treatment
时间窗: 12 months
次要结局
- Overall Response and Complete Remission Rate(12 months)
- Minimum Residual Disease (MRD)(12 months)