2024-514823-41-00Active, not recruitingPhase 2
Therapy with ibrutinib for patients with Chronic lymphocytic leukemia with subclonal TP53 aberrations
Clonal evolution in progressive CLL patients harboring subclonal TP53 aberrations treated with ibrutinib first-line
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Aug 2024
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 29 Apr 2019
- Lead sponsor
- Ospedale San Raffaele S.r.l.
- Diseases
- Chronic lymphocytic leukaemia
- EU CT number
- 2024-514823-41-00
- EudraCT number
- 2017-001099-49
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- >=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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Santa Croce E Carle | Cuneo | Italy | Active, not recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Active, not recruiting |
| Hospital Santa Maria Della Misericordia | Perugia | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale Dei Sette Laghi | Varese | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.