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NCT05999877 · ClinicalTrials.gov record · last posted 2026-08-04

PICAROS - Acalabrutinib RWE on 1L CLL in Spain

Study acronym: PICAROS
StatusActive, Not Recruiting
PhaseNot specified
Started2023-07-11
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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).

Protocol amendment history 4 changes detected by DataLookout

2026-08-05
critical
Primary endpoint(s) modified
WasProportion of patients on acalabrutinib therapy at 24 months after treatment initiation.
NowProportion of patients on acalabrutinib therapy at 24 months after treatment initiation (cohort 1)., Real-world overall response rate (rwORR) achieved until the end of the observational period for first-line fixed duration acalabrutinib therapy (cohort 2)
2026-08-05
minor
Trial arms changed: 0 → 2
2026-08-05
critical
Primary completion pushed: 2026-12-31 → 2029-03-31
2026-08-05
minor
Completion pushed: 2026-12-31 → 2029-03-31
Trial Details
NCT Number NCT05999877
Lead Sponsor AstraZeneca
Conditions Chronic Lymphocytic Leukemia
Enrollment 192 participants
Start Date 2023-07-11
Primary Completion 2029-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-04