NL-OMON50080已完成2 期
A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic Leukemia - M18-803
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
排除标准
- 未提供
研究者
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