NCT05999877Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 315 (estimated)
- First submitted
- 29 Jun 2023
- Start date
- 11 Jul 2023
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- AstraZeneca
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT05999877
What you commit to
- Study type: Observational
- Planned participants: 315
- From 11 Jul 2023 to the primary completion date, 31 Mar 2029
- 34 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.