A Phase 1/1b Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia or Select Subtypes of Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical activity in patients with CLL and non-Hodgkin's lymphoma.
详细描述
This Phase 1/1b open-label study consists of two parts. The initial portion is a Phase 1 dose-escalation study evaluating the safety and tolerability of TRU-016 administered over a 4-week period to patients with relapsed chronic lymphocytic leukemia (CLL). It will identify the MTD and evaluate the pharmacokinetics and immunogenicity of TRU-016. Upon demonstrating satisfactory safety and tolerability in the Phase 1 portion, a Phase 1b expansion cohort will be enrolled to further characterize the safety of the selected dose from the first stage of the study and safety and to estimate the clinical activity of TRU-016 in patients with treatment-naive CLL, relapsed CLL and non-Hodgkin's lymphoma.
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
- •Diagnosis of chronic lymphocytic lymphoma or small lymphocytic lymphoma (Phase 1) or relapsed/refractory NHL (Phase 1b)
- •Previous treatment with at least one fludarabine-containing regimen
- •Demonstrate at least one of the following criteria for active disease requiring treatment:
- •a)progressive splenomegaly and/or lymphadenopathy;
- •b)anemia or thrombocytopenia due to bone marrow involvement;
- •c)unintentional weight loss >10% over preceding 6-month period;
- •d) NCI Grade 2 or 3 fatigue;
- •e) fevers >100.5 F or night sweats for > 2 weeks without infection;
- •f) progressive lymphocytosis with increase of >50% over a 2-month period or anticipated doubling time of < 6 months.
- •ECOG performance status </= 2
- •SGOT, SGPT </= 2.0 x upper limit of normal
- •ANC >/= 500/uL
- •Platelets >/= 30,000/uL
- •Discontinued previous anticancer or investigational therapy for at least 30 days
排除标准
- •Treatment with rituximab within 30 days or alemtuzumab(Campath)or radioimmune therapy within 12 weeks
- •ANC </= 500/uL
- •Platelets </= 30,000/mm3
- •Previous or concurrent additional malignancy
- •Significant concurrent medical diseases or conditions
- •Hepatitis B surface antigen or hepatitis B core antibody positive
- •Pregnant or breastfeeding
研究组 & 干预措施
1
Dose escalation and expansion cohorts
干预措施: TRU-016 (anti-CD37 protein therapeutic) (Drug)
结局指标
主要结局
Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
时间窗: 4 weeks after treatment
次要结局
- Preliminary indication of response as defined by NCI 1996 criteria(3 months after treatment)