NCT02827617Completed
Identification of Biomarkers That Are Predictive of Early Ibrutinib Treatment Failure in High Risk TP53 Mutated Chronic Lymphocytic Leukemia
Prospective, Observational, Multi-centred, Non-interventional Study on the Identification of Biomarkers That Are Predictive of Early Ibrutinib Treatment Failure in High Risk TP53 Mutated Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
The general aim of the project is the identification of dynamic molecular markers that can help the early and real time prediction of sustained benefit or no benefit from ibrutinib treatment in CLL harboring TP53 mutations. Specific aims of the project include: 1) Assess whether clearance of TP53 mutated clones translates into a predictive biomarker of long term benefit from ibrutinib treatment in CLL. 2) Assess whether plasma cell free DNA represents a sensitive tool that can early and dynamically inform on the development of ibrutinib resistant mutations in CLL.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 56 (estimated)
- First submitted
- 6 Jul 2016
- Start date
- 1 Jun 2016
- Primary completion date
- 31 Aug 2021
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT02827617
What you commit to
- Study type: Observational
- Planned participants: 56
- From 1 Jun 2016 to the primary completion date, 31 Aug 2021
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation).
- Prior treatment with ibrutinib or idelalisib
Who the study is looking for
- Male or female adults 18 years or older
- Documented diagnosis of CLL, according to iwCLL 2008 criteria
- Presence of TP53 mutation as demonstrated by sequencing at the local laboratory and/or presence of 17p deletion as demonstrated by fluorescence in situ hybridization (FISH) testing performed at the local laboratory
- CLL that warrants treatment
- Planned treatment with ibrutinib 420 mg quaque die
- Willing and able to comply with scheduled visits, laboratory tests, and study procedures
- Evidence of a signed informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Hematology, Department of Internal Medicine, Basel University Hospital Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Oncology Institute of Southern Switzerland Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Unknown status |
| Hematology, Luzern Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Clinica Luganese Moncucco Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Onco Ematologia Clinico Sperimentale, I.R.C.C.S. Centro di Riferimento Oncologico Coordinator of this site? Confirm its status | Aviano | Italy | Unknown status |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Dipartimento di Ematologia, Niguarda Cancer Center, Ospedale Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Department of Medical and Surgical Sciences, section of Hematology Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Divisione di Ematologia, Universita' del Piemonte Orientale Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Institute of Hematology, Catholic University S. Cuore Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Department of Haematology, Tor Vergata Hospital Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Clinica Ematologica, Centro Trapianti e Terapie Cellulari "Carlo Melzi" Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.