A Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination With TGR-1202, a Novel PI3k Delta Inhibitor; and Ibrutinib or Bendamustine, in Patients With B-cell Malignancies.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose acceptable for participants
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies
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 B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair
- •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
- •Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
- •Primary central nervous system lymphoma or known intracranial involvement
研究组 & 干预措施
Ublituximab + TGR-1202
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose
干预措施: Ublituximab + TGR-1202 (Drug)
Ublituximab + TGR-1202 + ibrutinib
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose ibrutinib oral daily dose
干预措施: Ublituximab + TGR-1202 + ibrutinib (Drug)
Ublituximab + TGR-1202 + bendamustine
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Bendamustine at a fixed IV infusion on Days 1 & 2
干预措施: Ublituximab + TGR-1202 + bendamustine (Drug)
结局指标
主要结局
Maximum Tolerated Dose acceptable for participants
时间窗: 28 days (1 cycle 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)