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REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy. A FILO Study.
Data evaluating and quantifying real-world outcomes of patients post-ibrutinib discontinuation, as well as outcomes of patients who have progressed on a Bruton tyrosine kinases inhibitors (BTKi) and received prior venetoclax are very limited. There are no robust studies specifically designed to assess outcomes of patients with chronic lymphocytic leukemia (CLL) receiving third line or subsequent treatments. As such, there is no established standard of care for these multiple Relapsed/Refractory (RR) patients. Furthermore, despite new oral agents approved in third-line RR CLL, there are limited published data on how to best sequence these agents and how to manage patients who fail these therapies. As the best salvage therapy in patients who fail all available oral these agents is unknown, this is a population of patients with unmet medical need. The aim of this study is to determine unmet need and treatment patterns of data from two types of populations, all previously exposed to ibrutinib (or other BTKi) for the full patient population and both ibrutinib (or other BTKi and venetoclax) for the narrow patient population, where these agents failed these subcategories of patient populations, at least in 3rd line therapy (in other words, having at least received two lines of therapy before) * Patients with prior treatment with BTKi (full patient population) - Underlying tenet: these patients have been treated with a BTKi in at least one of two or more prior lines of therapy and progressed - FULL POPULATION * Patients who progressed BTKi and failed VEN (defined as patients who discontinued venetoclax (VEN) due to disease progression, intolerability, or failure to achieve an objective response within 3 months of initiating therapy; small patient population) - Tenet: these patients have been treated with both BTKi and VEN in any one of the prior two lines of therapy and progressed. - NARROW POPULATION
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU Estaing - Hématologie Clinique Adulte
Clermont-Ferrand, France
Centre Léon Bérard - Hématologie
Lyon, France
Institut Paoli-Calmettes - Hématologie Clinique
Marseille, France
MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique
Montpellier, France
Bordeaux Pessac
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Strasbourg - Icans
Strasbourg, France
Toulouse - IUCT Oncopole - Service d'Hématologie
Toulouse, France
Start Date
January 25, 2023
Primary Completion Date
December 31, 2023
Completion Date
March 31, 2024
Last Updated
December 3, 2025
152
ACTUAL participants
Lead Sponsor
French Innovative Leukemia Organisation
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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