PICAROS - Acalabrutinib RWE on 1L CLL in Spain
ConditionChronic Lymphocytic Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old at starting acalabrutinib treatment.
Diagnosis of CLL.
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).
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
315 Participants
are grouped into 2 trial groupsGroup A: Cohort 1
Group B: Cohort 2
Trial outcomes
Primary outcomes
1
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).
Time frame
24 months after treatment initiation (cohort 1).2
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.
Time frame
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
1
Acalabrutinib±venetoclax doses (cohorts 1 and 2).
Acalabrutinib±venetoclax doses (e.g., starting does and dose adjustments), overall (cohorts 1 and 2) and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only). In cohort 2, doses (e.g., starting dose, dose adjustments, maximum dose achieved) and reasons for changes within the acalabrutinib±venetoclax fixed-duration regimen will also be described globally and for each drug separately, as well as the time to reach the maximal dose.
Time frame
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 2.2
Patients with acalabrutinib±venetoclax dose adjustments (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %) (cohorts 1 and 2).
Acalabrutinib±venetoclax dose adjustments, temporary interruptions, and permanent discontinuations, overall (cohorts 1 and 2) and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only). In patients with regimen modifications within cohort 2, the proportion of patients with these regimen modifications and the time from treatment initiation to the regimen modification within same line therapy prior to progression (e.g., treatment duration and number of cycles prior to the modification, and reason for the modification). In cohort 2, temporary interruptions, permanent discontinuations, and their reasons for changes within the acalabrutinib±venetoclax fixed-duration regimen will also be described globally and for each drug separately, as well as the proportion of patients requiring dose reductions after achieving maximum dose.
Time frame
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 2.3
Treatment duration in months (cohorts 1 and 2).
Treatment duration (cohorts 1 and 2), overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only). In cohort 2, also median number of completed cycles and the proportion of patients who complete 14 cycles. Baseline patient characteristics associated with treatment duration in multivariate analyses, overall (cohorts 1 and 2) and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1 only).
Time frame
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 2.4
Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib (cohort 1).
Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression) (cohort 1). The PDC will be based on data available on acalabrutinib treatment in pharmacy records, and defined as the percentage of days a patient has the medication available in a given period of time: PDC (%)=(No.days covered)/(No.days of interest)×100
Time frame
From acalabrutinib start to acalabrutinib end, assessed up to 32 months of prospective study follow-up (cohort 1).Sponsors and contacts
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Source ClinicalTrials.gov