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

Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL): Analysis of Real-life Data: Snapshot at 3 Years From the End of Ibrutinib ATU. A National Study of the FILO-LLC Group

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03502876

Enrollment

198

Registered

2018-04-19

Start date

2017-11-02

Completion date

2019-12-31

Last updated

2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B Cell Chronic Lymphocytic Leukemia

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results