NCT03207256终止2 期
An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities
研究概览
简要总结
This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
- •Subjects must have completed at least 6 cycles of therapy on their current protocol.
排除标准
- •Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.
研究组 & 干预措施
TGR-1202
Experimental
Oral TGR-1202 Daily
干预措施: TGR-1202 (Drug)
TGR-1202 + Ublituximab
Experimental
Oral TGR-1202 in combination with Ublituximab intravenous administration
干预措施: TGR-1202 + Ublituximab (Drug)
结局指标
主要结局
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities
时间窗: Evaluated at each planned visit through study completion, an average of 2 years
Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)
次要结局
- Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment(Evaluated at each planned visit through study completion, an average of 2 years)
研究者
研究点 (2)
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