Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL

Completed

• Conditions: B Cell Chronic Lymphocytic Leukemia

• Registration Number: NCT03502876
• Lead Sponsor: French Innovative Leukemia Organisation

Brief Summary

Assessment of the mutational profile of the residual clone and the distribution of lymphocyte subpopulations at 3 years of treatment with ibrutinib

This project has an epidemiological part: to establish the percentage of patients, in a real-life situation, still undergoing treatment 3 years after its initiation, as well as a biological part: to determine the evolution of the clone and the prevalence of BTK mutations and PLCg2 in the absence of clinical or biological criteria for scalability.

Detailed Description

Observationnal and biological study

Study Timeline

• Study Start: 2017-11-02
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-19
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• patients included in the ATU (epidemiology)
• under treatment at 3 years of ibrutinib
• more than 18 years old

Exclusion Criteria

• no ibrutinib treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ibrutinib resistance	under treatment at 3 years of ibrutinib	In the long term, this study will help to draft new recommendations from FILO-LLC concerning the detection of resistance and the management of patients.

Trial Locations

Locations (2)

Project manager; 🇫🇷 Tours, France

FILO French Innovative Leukemia Organization; 🇫🇷 Tours, France