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
192
1 country
47
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2023
Typical duration for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 10, 2026
March 1, 2026
3.5 years
June 29, 2023
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation.
Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation. In addition to this outcome measured in the overall population, 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.
Secondary Outcomes (7)
Start dose in mg.
At acalabrutinib start date
Patients with acalabrutinib dose reductions (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %).
From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Treatment duration in months.
From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib.
From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
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 [i.e. deaths are not censored]).
From the date of first dose of acalabrutinib to the first dose of the next treatment for CLL or death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.
- +2 more secondary outcomes
Other Outcomes (6)
Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment.
From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause).
From the date of first dose of acalabrutinib to disease progression or death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.
Scores on the EORTC QLQ-C30, its specific module for CLL QLQ-CLL17, and SATMED-Q during acalabrutinib treatment.
Study inclusion, month 3, month 6 and subsequent every 6 months during acalabrutinib treatment up to 3.5 years of prospective study follow-up.
- +3 more other outcomes
Eligibility Criteria
The study aims to include approximately 315 patients who started acalabrutinib for the first time for the treatment of their CLL. They may include patients receiving acalabrutinib either as first treatment for their previously untreated CLL or patients who switched from first generation BTK inhibitor, used in first-line, to acalabrutinib due to intolerance. 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. The identification of patients for inclusion will be consecutive backwards until reaching a maximum of 15 patients per site.
You may qualify if:
- Age ≥18 years old at starting acalabrutinib treatment.
- Diagnosis of CLL.
- 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 (47)
Research Site
Almería, Andalusia, 4009, Spain
Research Site
Córdoba, Andalusia, 14004, Spain
Research Site
Granada, Andalusia, 18014, Spain
Research Site
Jaén, Andalusia, 23007, Spain
Research Site
Marbella, Andalusia, 29603, Spain
Research Site
Málaga, Andalusia, 29010, Spain
Research Site
Seville, Andalusia, 41013, Spain
Research Site
Zaragoza, Aragon, 50009, Spain
Research Site
Palma de Mallorca, Balearic Islands, 7010, Spain
Research Site
Palma de Mallorca, Balearic Islands, 7198, Spain
Research Site
Las Palmas de Gran Canaria, Canary Islands, 35016, Spain
Research Site
Las Palmas de Gran Canaria, Canary Islands, 35019, Spain
Research Site
San Cristóbal de La Laguna, Canary Islands, 38320, Spain
Research Site
Santander, Cantabria, 39008, Spain
Research Site
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
Research Site
Guadalajara, Castille-La Mancha, 19002, Spain
Research Site
Toledo, Castille-La Mancha, 45004, Spain
Research Site
Barcelona, Catalonia, 8003, Spain
Research Site
Barcelona, Catalonia, 8025, Spain
Research Site
Barcelona, Catalonia, 8035, Spain
Research Site
Barcelona, Catalonia, 8036, Spain
Research Site
Granollers, Catalonia, 8402, Spain
Research Site
L'Hospitalet de Llobregat, Catalonia, 8908, Spain
Research Site
Lleida, Catalonia, 25198, Spain
Research Site
Terrassa, Catalonia, 8221, Spain
Research Site
Ourense, Galicia, 32005, Spain
Research Site
Santiago de Compostela, Galicia, 15706, Spain
Research Site
Vigo, Galicia, 36312, Spain
Research Site
Madrid, Madrid, 28006, Spain
Research Site
Madrid, Madrid, 28031, Spain
Research Site
Madrid, Madrid, 28034, Spain
Research Site
Madrid, Madrid, 28040, Spain
Research Site
Madrid, Madrid, 28041, Spain
Research Site
Madrid, Madrid, 28046, Spain
Research Site
Madrid, Madrid, 28905, Spain
Research Site
Madrid, Madrid, 28911, Spain
Research Site
Majadahonda, Madrid, 28222, Spain
Research Site
El Palmar, Murcia, 30120, Spain
Research Site
Murcia, Murcia, 30008, Spain
Research Site
Oviedo, Principality of Asturias, 33011, Spain
Research Site
Alicante, Valencia, 3010, Spain
Research Site
Valencia, Valencia, 46010, Spain
Research Site
Valencia, Valencia, 46014, Spain
Research Site
Valencia, Valencia, 46026, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 10, 2026
Record last verified: 2026-03
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.