Trial Title:
PICAROS - Acalabrutinib RWE on 1L CLL in Spain
NCT ID:
NCT05999877
Condition:
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Conditions: Keywords:
Observational
Chronic lymphocytic leukemia
Acalabrutinib
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Almeria
Zip:
4009
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Cordoba
Zip:
14004
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Granada
Zip:
18014
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Jaen
Zip:
23007
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Marbella
Zip:
29603
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Santander
Zip:
39008
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Guadalajara
Zip:
19002
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Toledo
Zip:
45004
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Segovia
Zip:
40002
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Valladolid
Zip:
47003
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Valladolid
Zip:
47012
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8003
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8025
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
8036
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Granollers
Zip:
8402
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Hospitalet de Llobregat
Zip:
8908
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Lleida
Zip:
25198
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Terrassa
Zip:
8221
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28006
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28031
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28905
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28911
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Alicante
Zip:
3010
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46014
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Ourense
Zip:
32005
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Vigo
Zip:
36312
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Palma de Mallorca
Zip:
7010
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Palma de Mallorca
Zip:
7198
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
La Laguna
Zip:
38320
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Las Palmas de Gran Canaria
Zip:
35016
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Las Palmas de Gran Canaria
Zip:
35019
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Murcia
Zip:
30008
Country:
Spain
Start date:
July 11, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999877
