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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

B Cell Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FILO French Innovative Leukemia Organization, Tours, France

About this study

Observationnal and biological study

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Ibrutinib resistance

Time frame: 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.

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Apr 19, 2018
Registry last updated: May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed