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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
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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Division of Hematology, Department of Internal Medicine, Basel University Hospital
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
Oncology Institute of Southern Switzerland
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BellinzonaSwitzerlandUnknown status
Hematology, Luzern Kantonsspital
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LucerneSwitzerlandUnknown status
Clinica Luganese Moncucco
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LuganoSwitzerlandUnknown status
Onco Ematologia Clinico Sperimentale, I.R.C.C.S. Centro di Riferimento Oncologico
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AvianoItalyUnknown status
Ospedale San Raffaele
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MilanItalyUnknown status
Dipartimento di Ematologia, Niguarda Cancer Center, Ospedale Niguarda
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Department of Medical and Surgical Sciences, section of Hematology
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ModenaItalyUnknown status
Divisione di Ematologia, Universita' del Piemonte Orientale
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NovaraItalyUnknown status
Institute of Hematology, Catholic University S. Cuore
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RomaItalyUnknown status
Department of Haematology, Tor Vergata Hospital
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RomeItalyUnknown status
Clinica Ematologica, Centro Trapianti e Terapie Cellulari "Carlo Melzi"
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UdineItalyUnknown status
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
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VareseItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.