Therapy with ibrutinib for patients with Chronic lymphocytic leukemia with subclonal TP53 aberrations
Key facts
- Where
- Cuneo, Milan, Novara, Pavia, Perugia és Varese, OlaszországSee the 7 sites
- Phase
- 2. fázis
Where in Olaszország
- Azienda Ospedaliera Santa Croce E CarleCuneo, OlaszországNo longer taking part
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, OlaszországNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, OlaszországNo longer taking part
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, OlaszországNo longer taking part
- Fondazione IRCCS Policlinico San MatteoPavia, OlaszországNo longer taking part
- Hospital Santa Maria Della MisericordiaPerugia, OlaszországNo longer taking part
- Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ospedale San Raffaele S.r.l.
- Trial code
- EU 2024-514823-41-00
- Record updated
- 2024. augusztus 5.
- Original description
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)Read full original descriptionShow less
Clonal evolution in progressive CLL patients harboring subclonal TP53 aberrations treated with ibrutinib first-line
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)
Inclusion: >=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.
Exclusion: 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; Histologically documented transformation from CLL to aggressive lymphoma (Richter transformation); Evidence of clonal TP53 mutations detected by Sanger sequencing and/or del17p in =20% of the nuclei by FISH.