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Spots Global Cancer Trial Database for REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy

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Trial Identification

Brief Title: REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy

Official Title: REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy

Study ID: NCT05621148

Interventions

Study Description

Brief Summary: 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

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Loïc YSEBAERT

Affiliation: French Innovative Leukemia Organisation

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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