A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 710
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma
详细描述
The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL, SLL, MZL, DLBCL and MCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of Non-Hodgkin's Lymphoma including Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma
- •Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
- •MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)
排除标准
- •Any major surgery, chemotherapy or immunotherapy within the last 21 days
- •Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
- •Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
- •Prior therapy with a PI3K delta inhibitor
研究组 & 干预措施
Umbralisib + Ublituximab
Umbralisib oral daily dose in combination with Ublituximab intravenous administration
干预措施: Ublituximab (Biological)
Umbralisib + Ublituximab
Umbralisib oral daily dose in combination with Ublituximab intravenous administration
干预措施: Umbralisib (Drug)
Umbralisib
Umbralisib oral daily dose
干预措施: Umbralisib (Drug)
Umbralisib + Ublituximab + Bendamustine
Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
干预措施: Ublituximab (Biological)
Umbralisib + Ublituximab + Bendamustine
Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
干预措施: Umbralisib (Drug)
Umbralisib + Ublituximab + Bendamustine
Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
干预措施: Bendamustine (Biological)
结局指标
主要结局
Overall Response Rate
时间窗: Every 8-12 weeks, up to 2 years
次要结局
- Progression-Free Survival(From date of randomization until the date of first documented progression, assessed up through 2 years)