PICAROS - Acalabrutinib RWE on 1L CLL in Spain (NCT05999877) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PICAROS - Acalabrutinib RWE on 1L CLL in Spain
Spain192 participantsStarted 2023-07-11
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is observational and is no longer recruiting — does that mean there's any way for me to access acalabrutinib as a first-line treatment for my CLL outside of a trial, and would my doctor consider it a reasonable option for me?
2Since this is a real-world evidence study rather than a randomized controlled trial, what does that mean for how strong the safety and effectiveness data will be compared to a traditional clinical trial, and how should I weigh that when thinking about acalabrutinib?
3One group in this study is tracking how many patients are still on acalabrutinib at 24 months — what would cause someone to stop the drug before that point, and are those reasons something relevant to my specific situation?
4The second group is looking at a fixed-duration course of acalabrutinib rather than ongoing treatment — can my doctor explain the difference between fixed-duration and continuous therapy for CLL, and which approach might make more sense for me?
5Given that this study is being done in Spain and is observational, is there a similar trial or real-world evidence program available where I am being treated, or should I be looking at other clinical trials or standard treatment options instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1).
Timeframe: 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)
Timeframe: 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.