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Non-interventional Cohort Study of Patients Previously Untreated or First-generation BTKi Intolerant With Chronic Lymphocytic Leukemia Describing the First-line Use of Acalabrutinib and Its Real-world Outcomes in Spain: the PICAROS Study
This is a multicenter non-interventional study (NIS) on patients with CLL who have been treated with acalabrutinib for the first time within the year before the first site initiation visit in Spain
This is a multicenter, non-interventional study (NIS) based on ambispective (including retrospective and/or prospective) real-world data collection of patients with CLL who have been treated with acalabrutinib for the first time within the year before the first site initiation visit, from approximately 50 Hospitals in Spain. Patients who had already initiated acalabrutinib therapy will be identified by the investigators and offered to participate in the study. The start of acalabrutinib treatment (index date) must be prior to the first site initiation visit. Therefore, the clinical decision of starting patient on acalabrutinib has independently occurred prior to the patient inclusion into this study. Patients' eligibility for study inclusion is regardless of their current status of acalabrutinib therapy, for example, patients already deceased or discontinued therapy are still eligible to be included into this study. Patient data will be collected both retrospectively and/or prospectively up to 3.5 years from the first site initiation visit. For patients who received acalabrutinib therapy and have deceased, only retrospective medical chart review will be conducted.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Almería, Andalusia, Spain
Research Site
Córdoba, Andalusia, Spain
Research Site
Granada, Andalusia, Spain
Research Site
Jaén, Andalusia, Spain
Research Site
Marbella, Andalusia, Spain
Research Site
Málaga, Andalusia, Spain
Research Site
Seville, Andalusia, Spain
Research Site
Zaragoza, Aragon, Spain
Research Site
Palma de Mallorca, Balearic Islands, Spain
Research Site
Palma de Mallorca, Balearic Islands, Spain
Start Date
July 11, 2023
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
March 10, 2026
192
ACTUAL participants
Lead Sponsor
AstraZeneca
NCT05006716
NCT07277231
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06859424