Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 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
The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.
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
- •Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
- •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 14 days
- •Known hepatitis B virus, hepatitis C virus or HIV infection
- •Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
研究组 & 干预措施
TG-1501 + Ublituximab + Umbralisib
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
干预措施: Umbralisib (Drug)
TG-1501 + Ublituximab + Umbralisib
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
干预措施: ublituximab (Biological)
TG-1501 + Ublituximab + Umbralisib
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
干预措施: TG-1501 (Biological)
结局指标
主要结局
Determine Acceptable Adverse Events That Are Related to Treatment
时间窗: 6 months of therapy
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
次要结局
- Overall Response Rate(Up to 1 year)