Clinical trial · Observational
AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
QoL is often not assessed in real-world studies; hence, there is limited understanding about the real-world QoL of patients diagnosed with CLL. Besides, studies evaluating QoL have largely focused on comparing treated and untreated populations. In particular, QoL of patients treated with acalabrutinib has not been evaluated in a real-life setting. The aim of this study is to describe the QoL of CLL patients treated with acalabrutinib between the treatment initiation and twelve months after, in a real-life setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To measure QoL score of CLL patients treated with acalabrutinib, from treatment initiation and up to 12 months
- timeFrame
- From treatment initiation and up to 12 months
- description
- * Overall scores and scores in each domain of QoL questionnaires (EORTC-QLQ-C30 ) at acalabrutinib treatment initiation and at 3, 6, 9 and 12 months after initiation * Proportion of patients with an increase, a decrease, or no change in QoL scores over time (between each time point)
Secondary outcomes (3)
- measure
- To describe QoL and precisely the level of all symptoms
- timeFrame
- Treatment initiation
- description
- * Patients demographics at acalabrutinib treatment initiation * Clinical characteristics at acalabrutinib treatment initiation
- measure
- To describe QoL and precisely the level and evolution of all symptoms
- timeFrame
- From treatment initiation and up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available