Quality of life for people with CLL treated with acalabrutinib in France (PLATON database retrospective analysis)
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
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 |
|---|---|
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | Obinutuzumab, acalabrutinib |
| Locations | 1 site (Saint-Affrique) |
| Trial ID | NCT06548152 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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
Where this trial is running
Saint-Affrique
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.