NCT02013128已完成1 期
A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies
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 Ibrutinib in patients with advanced hematologic malignancies.
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 Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
- •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. Prior Allogeneic hematologic stem cell transplant is excluded.
- •Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma
研究组 & 干预措施
Ublituximab + ibrutinib
Experimental
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
干预措施: Ublituximab (Drug)
Ublituximab + ibrutinib
Experimental
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
干预措施: Ibrutinib (Drug)
结局指标
主要结局
To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies
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)
研究者
研究点 (1)
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