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

NCT02827617 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2025-11-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ibrutinib

Treatment with ibrutinib 420 mg quaque die in the clinical practice

Sponsors & Collaborators

  • Oncology Institute of Southern Switzerland

    lead OTHER

Principal Investigators

  • Davide Rossi, MD, PhD · Oncology Institute of Southern Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2021-08-31
Completion
2024-05-16

Countries

  • Italy
  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02827617 on ClinicalTrials.gov