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PICAROS - Acalabrutinib RWE on 1L CLL in Spain

Study acronym: PICAROS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Dec 31, 2026 → Mar 31, 2029
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from AstraZeneca

Record History

  1. Enrollment reopened Enrollment increased: 192 → 315 participants · Study sites: 47 to 49 · Eligibility criteria expanded, about 8 words · 1 more Show 4 more changesShow less
    • Enrollment increased: 192 → 315 participants
    • Study sites: 47 to 49
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 6 of 7 entries
  2. Primary and study completion pushed from Dec 31, 2026 to Mar 31, 2029 Primary endpoint(s) modified · Trial arms changed: 0 → 2 · Eligibility criteria expanded, about 39 words · 2 morev20 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Trial arms changed: 0 → 2
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 64 words

    See this version in full on ClinicalTrials.gov ↗

  3. 8 versions Re-verified since Sep 2, 2024, no change to tracked fieldsv12-v19
  4. Enrollment target: 193 to 192 Study sites: 49 to 47v11 Show 1 more changeShow less
    • Study sites: 49 to 47
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 315 to confirmed 193 · Site details revised at 49 of 49 sitesv10 Show 2 more changesShow less
    • Enrollment target: estimated 315 to confirmed 193
    • Site details revised at 49 of 49 sites
Show 8 earlier versionsHide 8 earlier versions
  1. 3 versions Re-verified since Jan 10, 2024, no change to tracked fieldsv7-v9
  2. Study sites: 48 to 49v6
  3. Study sites: 47 to 48v5
  4. Study sites: 45 to 47v4
  5. Study sites: 39 to 45v3
  6. Study sites: 37 to 39v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05999877
Lead Sponsor AstraZeneca
Conditions Chronic Lymphocytic Leukemia
Enrollment 315 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov