NCT06548152 AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database
| NCT ID | NCT06548152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Chronic Lymphocytic Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
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.
Eligibility 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
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