An Open-label, Multi-centre, Phase Ib Trial to Determine the Dose of Intravenous BI 836826 in Combination With Oral Venetoclax in Chronic Lymphocytic Leukaemia Patients Who Are Eligible for Treatment With Venetoclax
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Maximum tolerated dose (MTD) based on the number of patients with dose limiting toxicities (DLTs) in the MTD evaluation period
研究概览
简要总结
The main objective of this trial is to determine the maximum tolerated dose (MTD) of BI 836826 in combination with venetoclax on the basis of dose limiting toxicities (DLTs incidence rate during the MTD evaluation period of the combination treatment and to determine the recommended Phase II dose (RP2D) of the combination.
Other objectives are to evaluate the pharmacokinetics of BI 836826 in combination with venetoclax and to further determine the safety, as well as to evaluate the efficacy of the combination by means of the Complete Response (CR) rate and Minimal Residual Disease (MRD) negativity rate.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
Venetoclax + BI 836826
干预措施: Venetoclax (Drug)
Venetoclax + BI 836826
干预措施: BI 836826 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) based on the number of patients with dose limiting toxicities (DLTs) in the MTD evaluation period
时间窗: up to 28 days
Number of patients with dose limiting toxicities (DLTs) in the Maximum tolerated dose (MTD) evaluation period
时间窗: up to 28 days
次要结局
- Area under the plasma concentration-time curve at steady-state (AUCtau) of BI 836826 when administered in combination with venetoclax with an observation time of 28 days in Cycle 1 of the combination.(up to 28 days)
- Complete response (CR) defined by investigator's assessment based on response assessment at imaging time points, analysed by complete response rate(up to 36 months)
- Minimal residual disease (MRD) negativity based on blood and analysed by MRD negativity rate(up to 36 months)
- Minimal residual disease (MRD) negativity based on bone marrow and analysed by MRD negativity rate(up to 36 months)