Clonal evolution in progressive CLL patients harboring subclonal TP53 aberrations treated with ibrutinib first-line

Ospedale San Raffaele S.r.l.0 个研究点目标入组 120 人开始时间: 2024年7月2日最近更新: 2024年8月21日

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•>=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

•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

发起方

Ospedale San Raffaele S.r.l.