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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncology Institute of Southern Switzerland

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Current or prior histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation).

• Prior treatment with ibrutinib or idelalisib