Quality of life for people with CLL treated with acalabrutinib in France (PLATON database retrospective analysis)
Official title: AQUALIS: Quality of Life of Patients With Chronic Lymphocytic Leukemia Treated With Acalabrutinib in France: a Retrospective Observational Study Based on Data Extracted From the PLATON Database
Run by AstraZeneca · NCT06548152 · Data updated 2026-11-12
This project will test how quality of life changes during the first 12 months in adults with CLL who start acalabrutinib in real-world care in France.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | Obinutuzumab, acalabrutinib |
| Locations | 1 site (Saint-Affrique) |
| Status | Recruiting |
| Started | April 28, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06548152 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with treatment‑naïve CLL who are enrolled in the French PLATON database and who began acalabrutinib (alone or with obinutuzumab) are the eligible group.
✕Probably not a fit
People who are pregnant, under legal protection, unable to give non-opposition, have prior CLL treatments, or who are not in the PLATON database will not be included and therefore will not directly benefit from this analysis.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective observational analysis using patient records from the French PLATON database to describe quality of life from treatment start through 12 months in adults with CLL treated with acalabrutinib, either alone or with obinutuzumab. The analysis will include treatment‑naïve patients recorded in PLATON, including those who discontinue acalabrutinib before 12 months. Quality-of-life measures captured in the database will be summarized over time and described by key clinical and demographic subgroups. No new treatments or procedures are performed because the project analyzes existing routine-care data.
Why it matters
Potential benefit: If successful, the results could give patients and clinicians clearer expectations about quality-of-life changes during the first year on acalabrutinib, helping inform treatment decisions.
How similar studies have gone: Large phase III trials (ELEVATE‑TN, ASCEND, ELEVATE‑R/R) established acalabrutinib's safety and efficacy, but real-world quality-of-life data for acalabrutinib are limited, so this analysis addresses a relatively under-studied area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The following patients will be eligible for inclusion in the AQUALIS study : * -Patient enrolled in the PLATON database * -Patient ≥18 years old * -Treatment naïve CLL patient treated with acalabrutinib in a real life setting. Treatment pattern is Acala mono or Acala + Obinutuzumab * -Patient who do not object to his health data collected in PLATON study being re-use for analysis/research purpose * -Patients who started Acala but discontinued before 12 months are also included. * Exclusion criteria: * -Pregnant women * -Patients under protection of justice * -Patients over the age of 18 and unable to express their non-opposition * -Patients with prior CLL treatments Exclusion Criteria:
Where it's running
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Research Site
Saint-Affrique, France Recruiting
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.