Identification of Biomarkers That Are Predictive of Early Ibrutinib Treatment Failure in High Risk TP53 Mutated Chronic Lymphocytic Leukemia

Sponsor
Oncology Institute of Southern Switzerland
Study ID
NCT02827617
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Treatment with ibrutinib 420 mg quaque die in the clinical practice

Study Details

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.

Key Dates

Start date
Jun 1, 2016
Status verified
Nov 2025
Primary completion
Aug 31, 2021
Completion
May 16, 2024

Study Design

Enrollment
56 participants (estimated)

Arms

  • Arm: TP53 mutated CLL

Primary Outcome Measure

Impact of clonal response on PFS [ Time Frame: 2/2016-2/2021 ]

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