Therapy with ibrutinib for patients with Chronic lymphocytic leukemia with subclonal TP53 aberrations

Phase 2

Active, not recruiting

• Conditions: Chronic Lymphocytic Leukemia (CLL)

• Registration Number: 2024-514823-41-00
• Lead Sponsor: Ospedale San Raffaele S.r.l.

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

=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 Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)]

Trial Locations

Locations (7)

Fondazione IRCCS Istituto Nazionale Dei Tumori; 🇮🇹 Milan, Italy

Ospedale San Raffaele S.r.l.; 🇮🇹 Milan, Italy

Azienda Socio Sanitaria Territoriale Dei Sette Laghi; 🇮🇹 Varese, Italy

Azienda Ospedaliera Santa Croce E Carle; 🇮🇹 Cuneo, Italy

Azienda Ospedaliero-Universitaria Maggiore Della Carita; 🇮🇹 Novara, Italy

Hospital Santa Maria Della Misericordia; 🇮🇹 Perugia, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori

🇮🇹Milan, Italy

Lucia Farina

Site contact

0223903696

lucia.farina@istitutotumori.mi.it