PICAROS - Acalabrutinib RWE on 1L CLL in Spain

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) 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).

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 received treatment with acalabrutinib for the first time 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).

For the cohort 1, the start of acalabrutinib treatment (index date) was prior to the first site initiation visit. For both cohorts 1 and 2, the clinical decision of starting patient on acalabrutinib has to independently occur 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 approximately 32 months from the first site initiation visit for cohort 1, and approximately 25 months after the inclusion of the last patient in the cohort 2. For patients who received acalabrutinib therapy and have deceased, only retrospective medical chart review will be conducted.

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.