2024-514823-41-00招募中2 期
Clonal evolution in progressive CLL patients harboring subclonal TP53 aberrations treated with ibrutinib first-line
Ospedale San Raffaele S.r.l.7 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年8月5日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- TP53 mutated subclone size at WEEK 2,4,12,24,48,72,96 and yearly thereafter compared to baseline [i.e. (TP53 mutated alleles at WEEK 2,4,12,24,48,72,96 and yearly thereafter)/(TP53 mutated alleles at baseline)]
研究概览
简要总结
To characterize the dynamics of the clonal composition in progressive CLL patients harboring TP53 mutations detected by NGS, at different time points (Baseline, Weeks 2,4, 12,24,48,72, 96 and then every year until the end of study, at disease progression)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •>=18 years old
- •Documented diagnosis of CLL according to International workshop on CLL (IwCLL) 2008 criteria
- •Previously untreated (steroid treatment previously administered to control autoimmune complications is allowed)
- •Negative HBsAg and negative HBcAb or positive HBcAb and negative for HBV DNA by quantitative PCR, HCV antibody negative or, in case of HCV antibody positive, HCV RNA negative
- •Progressive disease requiring treatment according to IwCLL 2008 criteria
- •Cohort 2 only: Evidence of a small (<20%) subclone carrying TP53 deletion by FISH
排除标准
- •Histologically documented transformation from CLL to aggressive lymphoma (Richter transformation)
- •History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- •Concomitant use of warfarin or other Vitamin K antagonists
- •Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
- •Evidence of clonal TP53 mutations detected by Sanger sequencing and/or del17p in =20% of the nuclei by FISH
结局指标
主要结局
TP53 mutated subclone size at WEEK 2,4,12,24,48,72,96 and yearly thereafter compared to baseline [i.e. (TP53 mutated alleles at WEEK 2,4,12,24,48,72,96 and yearly thereafter)/(TP53 mutated alleles at baseline)]
TP53 mutated subclone size at WEEK 2,4,12,24,48,72,96 and yearly thereafter compared to baseline [i.e. (TP53 mutated alleles at WEEK 2,4,12,24,48,72,96 and yearly thereafter)/(TP53 mutated alleles at baseline)]
次要结局
未报告次要终点
研究者
Paolo Ghia
Scientific
Ospedale San Raffaele S.r.l.
研究点 (7)
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