Follows adults with chronic lymphocytic leukemia treated with acalabrutinib in Spain
Observes real-world use of acalabrutinib as first treatment in chronic lymphocytic leukemia.
Plain-language title generated from the registry record
Registry title: PICAROS - Acalabrutinib RWE on 1L CLL in Spain
Key facts
- Where
- Alicante, Almería, Barcelona, Córdoba, Donostia / San Sebastian, El Palmar, Galdakao, Granada, Granollers, Guadalajara, Jaén, L'Hospitalet de Llobregat, Las Palmas de Gran Canaria, Lleida, Madrid, Majadahonda, Málaga, Marbella, Murcia, Ourense, Oviedo, Palma de Mallorca, Salamanca, San Cristóbal de La Laguna, Santander, Santiago de Compostela, Segovia, Seville, Terrassa, Toledo, Valencia, Valladolid, Vigo, and Zaragoza, SpainSee the 34 sites
Where in Spain
- AlicanteAlicante, SpainTaking people
- AlmeríaAlmería, SpainTaking people
- BarcelonaBarcelona, SpainNo longer taking part
- CórdobaCórdoba, SpainTaking people
- Donostia / San SebastianDonostia / San Sebastian, SpainNo longer taking part
- El PalmarEl Palmar, SpainNo longer taking part
- GaldakaoGaldakao, SpainNo longer taking part
- GranadaGranada, SpainTaking people
- GranollersGranollers, SpainNo longer taking part
- GuadalajaraGuadalajara, SpainTaking people
- JaénJaén, SpainNo longer taking part
- L'Hospitalet de LlobregatL'Hospitalet de Llobregat, SpainNo longer taking part
- Las Palmas de Gran CanariaLas Palmas de Gran Canaria, SpainNo longer taking part
- LleidaLleida, SpainNo longer taking part
- MadridMadrid, SpainTaking people
- MajadahondaMajadahonda, SpainNo longer taking part
- MálagaMálaga, SpainNo longer taking part
- MarbellaMarbella, SpainNo longer taking part
- MurciaMurcia, SpainTaking people
- OurenseOurense, SpainTaking people
- OviedoOviedo, SpainNo longer taking part
- Palma de MallorcaPalma de Mallorca, SpainNo longer taking part
- SalamancaSalamanca, SpainNo longer taking part
- San Cristóbal de La LagunaSan Cristóbal de La Laguna, SpainTaking people
- SantanderSantander, SpainNo longer taking part
- Santiago de CompostelaSantiago de Compostela, SpainNo longer taking part
- SegoviaSegovia, SpainNo longer taking part
- SevilleSeville, SpainTaking people
- TerrassaTerrassa, SpainNo longer taking part
- ToledoToledo, SpainNo longer taking part
- ValenciaValencia, SpainNo longer taking part
- ValladolidValladolid, SpainNo longer taking part
- VigoVigo, SpainTaking people
- ZaragozaZaragoza, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT05999877
- Record updated
- 4 November 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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.