Clinical trial NCT05999877: PICAROS - Acalabrutinib RWE on 1L CLL in Spain
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Keywords: Observational
Chronic lymphocytic leukemia
Acalabrutinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation.
timeFrame: 24 months after treatment initiation.
Secondary outcomes:
measure: Start dose in mg.
timeFrame: At acalabrutinib start date
measure: Patients with acalabrutinib dose reductions (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %).
timeFrame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
measure: Treatment duration in months.
timeFrame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
measure: Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib.
timeFrame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
measure: 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]).
timeFrame: 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.
measure: OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause).
timeFrame: 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.
measure: 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.
timeFrame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Other outcomes:
measure: Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment.
timeFrame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
measure: rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause).
timeFrame: 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.
measure: Scores on the EORTC QLQ-C30, its specific module for CLL QLQ-CLL17, and SATMED-Q during acalabrutinib treatment.
timeFrame: Study inclusion, month 3, month 6 and subsequent every 6 months during acalabrutinib treatment up to 3.5 years of prospective study follow-up.
measure: Frequency of patients switching from capsules to tablets (if available).
timeFrame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
measure: Patient satisfaction after switching from capsules to tablets (if available).
timeFrame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
measure: Patient adherence after switching from capsules to tablets (if available).
timeFrame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Locations:
city: Almeria
country: Spain
facility: Research Site
state: Andalucia
city: Cordoba
country: Spain
facility: Research Site
state: Andalucia
city: Granada
country: Spain
facility: Research Site
state: Andalucia
city: Jaen
country: Spain
facility: Research Site
state: Andalucia
city: Malaga
country: Spain
facility: Research Site
state: Andalucia
city: Marbella
country: Spain
facility: Research Site
state: Andalucia
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Zaragoza
country: Spain
facility: Research Site
state: Aragon
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Guadalajara
country: Spain
facility: Research Site
state: Castilla La Mancha
city: Toledo
country: Spain
facility: Research Site
state: Castilla La Mancha
city: Salamanca
country: Spain
facility: Research Site
state: Castilla Y Leon
city: Segovia
country: Spain
facility: Research Site
state: Castilla Y Leon
city: Valladolid
country: Spain
facility: Research Site
state: Castilla Y Leon
city: Valladolid
country: Spain
facility: Research Site
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Granollers
country: Spain
facility: Research Site
state: Cataluna
city: Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Cataluna
city: Lleida
country: Spain
facility: Research Site
state: Cataluna
city: Terrassa
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Majadahonda
country: Spain
facility: Research Site
state: Comunidad De Madrid
city: Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Ourense
country: Spain
facility: Research Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Vigo
country: Spain
facility: Research Site
state: Galicia
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Islas Baleares
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Islas Baleares
city: La Laguna
country: Spain
facility: Research Site
state: Islas Canarias
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
state: Islas Canarias
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
state: Islas Canarias
city: El Palmar
country: Spain
facility: Research Site
state: Region De Murcia
city: Murcia
country: Spain
facility: Research Site
state: Region De Murcia
Study officials:
References: