PICAROS - Acalabrutinib RWE on 1L CLL in Spain
PICAROS
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
1 other identifier
observational
315
1 country
49
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
September 28, 2026
September 1, 2026
5.7 years
June 29, 2023
September 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1).
Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1). In addition to this outcome measured in the overall cohort, it will also be assessed by the following factors: 1. the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression), 2. presence/absence of risk factors (i.e., del17p, TP53 mutation, and unmutated IGHV). 3. cardiovascular comorbidities (yes/no).
24 months after treatment initiation (cohort 1).
Real-world overall response rate (rwORR) achieved until the end of the observational period for first-line fixed duration acalabrutinib therapy (cohort 2)
rwORR (i.e., the proportion of patients that achieved complete or partial response) achieved until the end of the observational period for first-line fixed-duration acalabrutinib therapy as assessed by the treating physician (cohort 2). Complete response may include complete response, complete response with incomplete marrow recovery, or unconfirmed complete response (marrow biopsy not performed). Partial response may include partial response, or partial response with lymphocytosis. The rwORR will be assessed by the treating physician in routine clinical practice, including the use or not of the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. The end of observational period for first-line fixed-duration combinations of acalabrutinib is defined as the start date of a subsequent line therapy or study end date, whichever comes first.
From fixed-duration acalabrutinib start to the start date of a subsequent line therapy or study end date (cohort 2), assessed up to 25 months after the inclusion of the last patient in the cohort 2.
Secondary Outcomes (7)
Acalabrutinib±venetoclax doses (cohorts 1 and 2).
At start date and subsequent dose adjustments during acalabrutinib±venetoclax administration assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Patients with acalabrutinib±venetoclax dose adjustments (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %) (cohorts 1 and 2).
From acalabrutinib±venetoclax start to acalabrutinib±venetoclax end, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Treatment duration in months (cohorts 1 and 2).
From acalabrutinib±venetoclax start to acalabrutinib±venetoclax end, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib (cohort 1).
From acalabrutinib start to acalabrutinib end, assessed up to 32 months of prospective study follow-up (cohort 1).
TTNT (i.e., the time from the date of first dose of acalabrutinib to the first dose of the next treatment for CLL, or death from any cause) (cohorts 1 and 2).
From the date of first dose of acalabrutinib to first dose of next CLL treatment or death, assessed up to 32 months of prospective study follow-up in the cohort 1 and 25 months after the inclusion of the last patient in the cohort 2.
- +2 more secondary outcomes
Study Arms (2)
Cohort 1
Patients who initiated treat-to-progression acalabrutinib for the first time within the year before the first site initiation visit as per routine clinical practice, both for previously untreated CLL and after switching in first line from another BTK inhibitor due to intolerance in absence of progression.
Cohort 2
Patients with first-line fixed-duration acalabrutinib use with venetoclax in routine clinical practice.
Eligibility Criteria
The study aims to include approximately 315 patients in the cohort 1 and 103 patients in the cohort 2 who started acalabrutinib for the first time for the treatment of their CLL. To minimize selection biases, all patients (alive or deceased) identified on acalabrutinib will be eligible for inclusion into the study. These patients will be included from approximately 50 hospitals distributed throughout Spain.
You may qualify if:
- 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).
- Informed consent (for alive patients).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (49)
Research Site
Almería, Andalusia, 4009, Spain
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Córdoba, Andalusia, 14004, Spain
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Granada, Andalusia, 18014, Spain
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Jaén, Andalusia, 23007, Spain
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Marbella, Andalusia, 29603, Spain
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Málaga, Andalusia, 29010, Spain
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Seville, Andalusia, 41013, Spain
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Zaragoza, Aragon, 50009, Spain
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Palma de Mallorca, Balearic Islands, 7010, Spain
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Palma de Mallorca, Balearic Islands, 7198, Spain
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Donostia / San Sebastian, Basque Country, 20014, Spain
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Galdakao, Basque Country, 48960, Spain
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Las Palmas de Gran Canaria, Canary Islands, 35016, Spain
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Las Palmas de Gran Canaria, Canary Islands, 35019, Spain
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San Cristóbal de La Laguna, Canary Islands, 38320, Spain
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Santander, Cantabria, 39008, Spain
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Salamanca, Castille and León, 37007, Spain
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Segovia, Castille and León, 40002, Spain
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Valladolid, Castille and León, 47003, Spain
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Valladolid, Castille and León, 47012, Spain
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Guadalajara, Castille-La Mancha, 19002, Spain
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Toledo, Castille-La Mancha, 45004, Spain
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Barcelona, Catalonia, 8003, Spain
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Barcelona, Catalonia, 8025, Spain
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Barcelona, Catalonia, 8035, Spain
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Barcelona, Catalonia, 8036, Spain
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Granollers, Catalonia, 8402, Spain
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L'Hospitalet de Llobregat, Catalonia, 8908, Spain
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Lleida, Catalonia, 25198, Spain
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Terrassa, Catalonia, 8221, Spain
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Ourense, Galicia, 32005, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Vigo, Galicia, 36312, Spain
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Madrid, Madrid, 28006, Spain
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Madrid, Madrid, 28031, Spain
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Madrid, Madrid, 28034, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, 28905, Spain
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Madrid, Madrid, 28911, Spain
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Majadahonda, Madrid, 28222, Spain
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El Palmar, Murcia, 30120, Spain
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Murcia, Murcia, 30008, Spain
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Oviedo, Principality of Asturias, 33011, Spain
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Alicante, Valencia, 3010, Spain
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Valencia, Valencia, 46010, Spain
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Valencia, Valencia, 46014, Spain
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Valencia, Valencia, 46026, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2023
First Posted
August 21, 2023
Study Start
July 11, 2023
Primary Completion (Estimated)
March 31, 2029
Study Completion (Estimated)
March 31, 2029
Last Updated
September 28, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.