EUCTR2018-002179-17-NL进行中（未招募）1 期
A Prospective, Open-Label, Single Arm, Phase 2, Multi-Center Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-cell Prolymphocytic Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female subjects, at least 18 years old, with a diagnosis of R/R T-PLL that requires treatment and suitable for oral administration of study drugs.
- •- Subjects should meet the following disease activity criteria: an Eastern Cooperative Oncology Group performance status = 2.
- •- Subjects should have laboratory values meeting the following criteria:
- •Alanine aminotransferase/aspartate aminotransferase = 3 × the upper limit of normal (ULN);
- •Adequate liver function as indicated by a total bilirubin = 1.5 x ULN (subjects with documented Gilbert's syndrome may have bilirubin > 1.5 × ULN)
- •Absolute neutrophil count > 1000/µL;
- •Platelet count > 50,000/µL;
- •Creatinine clearance = 50 mL/minute; and
- •Hemoglobin > 8 g/dL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- 未提供
研究者
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