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NCT Number: NCT05999877

PICAROS - Acalabrutinib RWE on 1L CLL in Spain

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Almería, Andalusia, Spain

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About this study

This is a multicenter, non-interventional study (NIS) based on ambispective (including retrospective and/or prospective) real-world data collection of patients with CLL who have been treated with acalabrutinib for the first time within the year before the first site initiation visit, from approximately 50 Hospitals in Spain. Patients who had already initiated acalabrutinib therapy will be identified by the investigators and offered to participate in the study.

The start of acalabrutinib treatment (index date) must be prior to the first site initiation visit. Therefore, the clinical decision of starting patient on acalabrutinib has independently occurred prior to the patient inclusion into this study. Patients' eligibility for study inclusion is regardless of their current status of acalabrutinib therapy, for example, patients already deceased or discontinued therapy are still eligible to be included into this study. Patient data will be collected both retrospectively and/or prospectively up to 3.5 years from the first site initiation visit. For patients who received acalabrutinib therapy and have deceased, only retrospective medical chart review will be conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old at starting acalabrutinib treatment.
  • Diagnosis of CLL.
  • Start of acalabrutinib treatment (index date) 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. 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.

Treatment and study plan

Primary outcomes

  1. Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation.

    Time frame: 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:

    • the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression),
    • presence/absence of risk factors (i.e., del17p, TP53 mutation, and unmutated IGHV).
    • cardiovascular comorbidities (yes/no).

Secondary outcomes

  1. Start dose in mg.

    Time frame: At acalabrutinib start date

    Acalabrutinib dose at starting treatment, 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).

  2. Patients with acalabrutinib dose reductions (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %).

    Time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.

    Acalabrutinib dose reductions, temporary interruptions, and permanent discontinuations, 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).

  3. Treatment duration in months.

    Time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.

    Treatment duration, 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).

    Baseline patient characteristics associated with treatment duration in multivariate analyses, overall 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).

  4. Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib.

    Time frame: 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, 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).

    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

  5. 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]).

    Time frame: 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.

    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]), overall 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).

  6. OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause).

    Time frame: From the date of first dose of acalabrutinib to death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.

    OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause), overall 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).

  7. Adverse events that lead to acalabrutinib dose changes, temporary interruptions, or permanent discontinuation. Adverse events that are considered serious during acalabrutinib treatment. Events of clinical interest.

    Time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.

    Adverse events that lead to acalabrutinib dose changes, temporary interruptions, or permanent discontinuation.

    Adverse events that are considered serious (including fatal events) during acalabrutinib treatment, globally and treatment related (when available).

    Events of clinical interest (atrial fibrillation, hypertension, bleeding, infections, ventricular arrhythmias, hepatotoxicity, secondary primary malignancies, cytopenia, and pneumonitis) during acalabrutinib treatment, globally and treatment related (when available).They will be described overall 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).

Other outcomes

  1. Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment.

    Time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.

    Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment, overall 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).

  2. rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause).

    Time frame: 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.

    rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause), overall 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).

  3. Scores on the EORTC QLQ-C30, its specific module for CLL QLQ-CLL17, and SATMED-Q during acalabrutinib treatment.

    Time frame: Study inclusion, month 3, month 6 and subsequent every 6 months during acalabrutinib treatment up to 3.5 years of prospective study follow-up.

    Scores on the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) and its specific module for CLL QLQ-CLL17 reported at inclusion, month 3, month 6 and subsequent every 6-month follow-up during acalabrutinib treatment.

    Satisfaction with acalabrutinib treatment reported at study inclusion, month 3, month 6 and subsequent every 6-month follow-up during acalabrutinib treatment (Treatment Satisfaction Questionnaire; SATMED-Q).

    These outcomes will be evaluated overall 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).

  4. Frequency of patients switching from capsules to tablets (if available).

    Time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.

    Frequency of patients switching from capsules to tablets (if available).

  5. Patient satisfaction after switching from capsules to tablets (if available).

    Time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.

    Patient satisfaction according to SATMED-Q scores after switching from capsules to tablets (if available).

  6. Patient adherence after switching from capsules to tablets (if available).

    Time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.

    Patient adherence according to PDC after switching from capsules to tablets (if available).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PICAROS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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