An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.
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
- •Relapsed or Refractory B-cell Lymphoma
- •Measurable or Evaluable Disease
- •Previously treated with at least one line of rituximab or a rituximab based therapy
- •Patients ineligible for high dose or combination chemotherapy + stem cell transplant
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- •No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology
排除标准
- •Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
- •Prior autologous or allogeneic stem cell transplantation within 3 months of study entry
- •History of severe hypersensitivity or anaphylaxis to prior rituximab
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements
- •Pregnant women
研究组 & 干预措施
ublituximab
Phase I:
4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will have infusions on Days 1, 8 and 15 of cycle 1 & 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply.
干预措施: Ublituximab (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Subjects will be followed for 4 weeks
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Maximum Tolerated Dose acceptable for participants
时间窗: Subjects will be followed for 4 weeks
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
次要结局
- Efficacy(Participants will be evaluated approximately every 8 - 12 weeks)