A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 12
- 主要终点
- Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
研究概览
简要总结
The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma with at least prior treatments.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patients with relapsed or refractory NHL
Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments
干预措施: BI 836826 (Drug)
结局指标
主要结局
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
时间窗: From the first administration of trial medication to 7 days after the second administration, upto 36 days
The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients. The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course. In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration.. A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
时间窗: From the first administration of trial medication to 7 days after the second administration, up to 36 days
Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).
次要结局
- Tumour Size Reduction(Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.)
- Best Overall Response Based on All Assessment(Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT))
- Best Overall Response Based on Imaging Data(Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.)
- Progression Free Survival (PFS)(from first treatment until disease progression or death from any cause, up to 12 months.)
- Failure Free Survival (FFS)(from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.)