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PICAROS - Acalabrutinib RWE on 1L CLL in Spain

NCT ID: NCT05999877

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-11

Study Completion Date

2026-12-31

Brief Summary

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This is a multicenter non-interventional study (NIS) on patients with CLL who have been treated with acalabrutinib for the first time within the year before the first site initiation visit in Spain

Detailed Description

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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 have been treated with acalabrutinib for the first time within the year before the first site initiation visit, from approximately 50 Hospitals in Spain. Patients who had already initiated acalabrutinib therapy will be identified by the investigators and offered to participate in the study.

The start of acalabrutinib treatment (index date) must be prior to the first site initiation visit. Therefore, the clinical decision of starting patient on acalabrutinib has independently occurred 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 3.5 years from the first site initiation visit. For patients who received acalabrutinib therapy and have deceased, only retrospective medical chart review will be conducted.

Conditions

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Chronic Lymphocytic Leukemia

Keywords

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Observational Chronic lymphocytic leukemia Acalabrutinib

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years old at starting acalabrutinib treatment.
* Diagnosis of CLL.
* Start of acalabrutinib treatment (index date) 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. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Almería, Andalusia, Spain

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Córdoba, Andalusia, Spain

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Granada, Andalusia, Spain

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Jaén, Andalusia, Spain

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Marbella, Andalusia, Spain

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Zaragoza, Aragon, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Las Palmas de Gran Canaria, Canary Islands, Spain

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Las Palmas de Gran Canaria, Canary Islands, Spain

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San Cristóbal de La Laguna, Canary Islands, Spain

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Santander, Cantabria, Spain

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Salamanca, Castille and León, Spain

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Segovia, Castille and León, Spain

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Valladolid, Castille and León, Spain

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Valladolid, Castille and León, Spain

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Guadalajara, Castille-La Mancha, Spain

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Toledo, Castille-La Mancha, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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Granollers, Catalonia, Spain

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L'Hospitalet de Llobregat, Catalonia, Spain

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Lleida, Catalonia, Spain

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Terrassa, Catalonia, Spain

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Ourense, Galicia, Spain

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Santiago de Compostela, Galicia, Spain

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Vigo, Galicia, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Majadahonda, Madrid, Spain

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El Palmar, Murcia, Spain

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Murcia, Murcia, Spain

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Oviedo, Principality of Asturias, Spain

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Alicante, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Countries

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Spain

Other Identifiers

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D8221R00003

Identifier Type: -

Identifier Source: org_study_id