NCT01275209已完成1 期
A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab
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
- 1
- 试验地点
- 5
- 主要终点
- Incidence rate of dose-limiting toxicities and adverse events
研究概览
简要总结
This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification
- •Documented CD40+ follicular lymphoma
- •Measurable lesion
- •Refractory to rituximab
- •Prior treatment with at least 1 chemotherapeutic regimen
- •18 years or older
- •WHO Performance Status grade 0, 1, or 2
- •Life expectancy > 3 months
- •Obtained written informed consent
排除标准
- •Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL)
- •History of another primary malignancy that is currently clinically significant or currently requires active intervention
- •Prior allogeneic stem cell transplantation
- •Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
- •Impaired cardiac function or clinically significant cardiac disease
- •History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
- •History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
- •Known diagnosis of human immunodeficiency virus (HIV) infection
- •Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C
- •Ongoing corticosteroid use (>10 mg/day prednisone or equivalent)
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
HCD122
Experimental
干预措施: HCD122 (Drug)
结局指标
主要结局
Incidence rate of dose-limiting toxicities and adverse events
时间窗: 2 years
次要结局
- Response rate(2 years)
研究者
研究点 (5)
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