PICAROS - Acalabrutinib RWE on 1L CLL in Spain

Chronic Lymphocytic Leukemia Clinical Trial

— PICAROS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05999877
• Other study ID #: D8221R00003
• Status: Active, not recruiting
• Start date: July 11, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Spain	Research Site	Alicante	Comunidad Valenciana
Spain	Research Site	Almeria	Andalucia
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Cordoba	Andalucia
Spain	Research Site	El Palmar	Region De Murcia
Spain	Research Site	Granada	Andalucia
Spain	Research Site	Granollers	Cataluna
Spain	Research Site	Guadalajara	Castilla La Mancha
Spain	Research Site	Hospitalet de Llobregat	Cataluna
Spain	Research Site	Jaen	Andalucia
Spain	Research Site	La Laguna	Islas Canarias
Spain	Research Site	Las Palmas de Gran Canaria	Islas Canarias
Spain	Research Site	Las Palmas de Gran Canaria	Islas Canarias
Spain	Research Site	Lleida	Cataluna
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Madrid	Comunidad De Madrid
Spain	Research Site	Majadahonda	Comunidad De Madrid
Spain	Research Site	Malaga	Andalucia
Spain	Research Site	Marbella	Andalucia
Spain	Research Site	Murcia	Region De Murcia
Spain	Research Site	Ourense	Galicia
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Palma de Mallorca	Islas Baleares
Spain	Research Site	Palma de Mallorca	Islas Baleares
Spain	Research Site	Salamanca	Castilla Y Leon
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Santiago de Compostela	Galicia
Spain	Research Site	Segovia	Castilla Y Leon
Spain	Research Site	Sevilla	Andalucia
Spain	Research Site	Terrassa	Cataluna
Spain	Research Site	Toledo	Castilla La Mancha
Spain	Research Site	Valencia	Comunidad Valenciana
Spain	Research Site	Valencia	Comunidad Valenciana
Spain	Research Site	Valencia	Comunidad Valenciana
Spain	Research Site	Valladolid	Castilla Y Leon
Spain	Research Site	Valladolid	Castilla Y Leon
Spain	Research Site	Vigo	Galicia
Spain	Research Site	Zaragoza	Aragon

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment.	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).	From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Other	rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause).	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).	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.
Other	Scores on the EORTC QLQ-C30, its specific module for CLL QLQ-CLL17, and SATMED-Q during acalabrutinib treatment.	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).	Study inclusion, month 3, month 6 and subsequent every 6 months during acalabrutinib treatment up to 3.5 years of prospective study follow-up.
Other	Frequency of patients switching from capsules to tablets (if available).	Frequency of patients switching from capsules to tablets (if available).	From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Other	Patient satisfaction after switching from capsules to tablets (if available).	Patient satisfaction according to SATMED-Q scores after switching from capsules to tablets (if available).	From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Other	Patient adherence after switching from capsules to tablets (if available).	Patient adherence according to PDC after switching from capsules to tablets (if available).	From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Primary	Proportion of patients on acalabrutinib therapy at 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).	24 months after treatment initiation.
Secondary	Start dose in mg.	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).	At acalabrutinib start date
Secondary	Patients with acalabrutinib dose reductions (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %).	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).	From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Secondary	Treatment duration in months.	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).	From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Secondary	Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib.	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	From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
Secondary	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]).	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).	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.
Secondary	OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause).	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).	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.
Secondary	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.	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).	From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.