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PICAROS - Acalabrutinib RWE on 1L CLL in Spain
PICAROS - Acalabrutinib RWE on 1L CLL in Spain

NCT05999877

Active Not RecruitingN/A

Sponsor: AstraZeneca

Conditions: Chronic Lymphocytic Leukemia

Countries: Spain

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (47)
  • Almería, Andalusia, Spain
  • Córdoba, Andalusia, Spain
  • Granada, Andalusia, Spain
  • Jaén, Andalusia, Spain
  • Marbella, Andalusia, Spain
  • Málaga, Andalusia, Spain
  • Seville, Andalusia, Spain
  • Zaragoza, Aragon, Spain
  • Palma de Mallorca, Balearic Islands, Spain
  • Palma de Mallorca, Balearic Islands, Spain
  • Las Palmas de Gran Canaria, Canary Islands, Spain
  • Las Palmas de Gran Canaria, Canary Islands, Spain
  • San Cristóbal de La Laguna, Canary Islands, Spain
  • Santander, Cantabria, Spain
  • Salamanca, Castille and León, Spain
  • Segovia, Castille and León, Spain
  • Valladolid, Castille and León, Spain
  • Valladolid, Castille and León, Spain
  • Guadalajara, Castille-La Mancha, Spain
  • Toledo, Castille-La Mancha, Spain
  • Barcelona, Catalonia, Spain
  • Barcelona, Catalonia, Spain
  • Barcelona, Catalonia, Spain
  • Barcelona, Catalonia, Spain
  • Granollers, Catalonia, Spain
  • L'Hospitalet de Llobregat, Catalonia, Spain
  • Lleida, Catalonia, Spain
  • Terrassa, Catalonia, Spain
  • Ourense, Galicia, Spain
  • Santiago de Compostela, Galicia, Spain
  • + 17 more on CT.gov