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PICAROS - Acalabrutinib RWE on 1L CLL in Spain

Recruitingn/aAges 18 Years - anyAllAstraZeneca
NCT05999877 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a multicenter non-interventional study (NIS) of patients with CLL treated with first-line acalabrutinib according to routine clinical practice in Spain. It included an initial cohort of patients who initiated treat-to-progression acalabrutinib for the first time within the year before the first site initiation visit, both for previously untreated CLL and after switching in first line from another BTK inhibitor due to intolerance in absence of progression (cohort 1). This cohort is complemented with the addition of another regarding the first-line fixed-duration acalabrutinib use with venetoclax in routine practice (cohort 2).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years old at starting acalabrutinib treatment. * Diagnosis of CLL. * Start of acalabrutinib treatment (index date) as per the CLL SmPC: * in treatment-naïve CLL patients or those switching in first-line between first-generation BTK inhibitor to acalabrutinib due to intolerance in absence of progression according to routine clinical practice within the year before the first site initiation visit (cohort 1). * in treatment-naïve CLL patients for the fixed-duration treatment combination of acalabrutinib plus venetoclax (with or without obinutuzumab) according to routine clinical practice from the EMA approval (i.e., 2 June 2025) (cohort 2). Decision to administer acalabrutinib must be made and documented prior to inclusion into the study and must follow local clinical practice. * Informed consent (for alive patients). Exclusion Criteria: * Enrolled in any clinical trial during acalabrutinib treatment. * Patients who are unable to understand the study and its questionnaires due to insufficient knowledge of the Spanish language or their health status.
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What it tests

  • Not listed
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Where

49 sites
Research Site
Almería, Spain
Research Site
Córdoba, Spain
Research Site
Granada, Spain
Research Site
Jaén, Spain
Research Site
Marbella, Spain
Research Site
Málaga, Spain
Research Site
Seville, Spain
Research Site
Zaragoza, Spain

…and 41 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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