NCT05999877From ClinicalTrials.govRecruiting

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

Chronic Lymphocytic Leukemia

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: AstraZeneca
Enrolment target: 315
Started: 11 July 2023
Main results due: 31 March 2029
Study sites: 49
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(49)

Research Site
Almería, Andalusia, Spain
Active, not recruiting
Research Site
Córdoba, Andalusia, Spain
Recruiting
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Granada, Andalusia, Spain
Recruiting
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Jaén, Andalusia, Spain
Active, not recruiting
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Marbella, Andalusia, Spain
Active, not recruiting
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Málaga, Andalusia, Spain
Active, not recruiting
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Seville, Andalusia, Spain
Recruiting
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Zaragoza, Aragon, Spain
Active, not recruiting
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Palma de Mallorca, Balearic Islands, Spain
Active, not recruiting
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Palma de Mallorca, Balearic Islands, Spain
Active, not recruiting
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Donostia / San Sebastian, Basque Country, Spain
Withdrawn
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Galdakao, Basque Country, Spain
Withdrawn
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Las Palmas de Gran Canaria, Canary Islands, Spain
Active, not recruiting
Research Site
Las Palmas de Gran Canaria, Canary Islands, Spain
Recruiting
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San Cristóbal de La Laguna, Canary Islands, Spain
Active, not recruiting
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Santander, Cantabria, Spain
Active, not recruiting
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Salamanca, Castille and León, Spain
Active, not recruiting
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Segovia, Castille and León, Spain
Active, not recruiting
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Valladolid, Castille and León, Spain
Active, not recruiting
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Valladolid, Castille and León, Spain
Active, not recruiting
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Guadalajara, Castille-La Mancha, Spain
Active, not recruiting
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Toledo, Castille-La Mancha, Spain
Active, not recruiting
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Barcelona, Catalonia, Spain
Active, not recruiting
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Barcelona, Catalonia, Spain
Active, not recruiting
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Barcelona, Catalonia, Spain
Active, not recruiting
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Barcelona, Catalonia, Spain
Active, not recruiting
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Granollers, Catalonia, Spain
Active, not recruiting
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L'Hospitalet de Llobregat, Catalonia, Spain
Active, not recruiting
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Lleida, Catalonia, Spain
Active, not recruiting
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Terrassa, Catalonia, Spain
Active, not recruiting
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Ourense, Galicia, Spain
Recruiting
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Santiago de Compostela, Galicia, Spain
Active, not recruiting
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Vigo, Galicia, Spain
Recruiting
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Madrid, Madrid, Spain
Recruiting
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Madrid, Madrid, Spain
Active, not recruiting
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Madrid, Madrid, Spain
Active, not recruiting
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Madrid, Madrid, Spain
Active, not recruiting
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Madrid, Madrid, Spain
Active, not recruiting
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Madrid, Madrid, Spain
Active, not recruiting
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Madrid, Madrid, Spain
Active, not recruiting
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Madrid, Madrid, Spain
Active, not recruiting
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Majadahonda, Madrid, Spain
Active, not recruiting
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El Palmar, Murcia, Spain
Active, not recruiting
Research Site
Murcia, Murcia, Spain
Recruiting
Research Site
Oviedo, Principality of Asturias, Spain
Active, not recruiting
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Alicante, Valencia, Spain
Active, not recruiting
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Valencia, Valencia, Spain
Active, not recruiting
Research Site
Valencia, Valencia, Spain
Active, not recruiting
Research Site
Valencia, Valencia, Spain
Active, not recruiting

Showing 49 of 49 sites. 8 of the 49 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05999877. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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