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.
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
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
The study population will be a subgroup of patients enrolled in PLATON database as described below. Inclusion criteria: The following patients will be eligible for inclusion : * 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
Cohort
Retrospective
Not listed
To measure QoL score of CLL patients treated with acalabrutinib, from treatment initiation and up to 12 months
* 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)
To describe QoL and precisely the level of all symptoms
* Patients demographics at acalabrutinib treatment initiation * Clinical characteristics at acalabrutinib treatment initiation
To describe QoL and precisely the level and evolution of all symptoms
* Clinical characteristics quarterly up to 12 months * Score is calculated with standardized EORTC-CLL17 questionnaire At acalabrutinib treatment initiation and at 3, 6, 9 and 12 months after initiation
Data outcomes analyze and link together
The severity of symptoms and the interference with daily living caused by these symptoms will be assessed using EORTC QLQ-CLL17 questionnaire. The overall scores of the QLQ-CLL17 questionnaire will be presented: at acalabrutinib treatment initiation and at 3, 6, 9 and 12 months after initiation. A mixed model will be used on repeated measurements of total QLQ-CLL17 score to study the evolution of QLQ-CLL17 after acalabrutinib treatment initiation. The model will be adjusted on age and sex and time of measurement as fixed effect. Disease status will be described quarterly up to 12 months after treatment initiation according to the following status: -missing value (patients not followed or missing score), complete response, partial response, partial response with lymphocytosis, stable disease, progressive disease Disease status will be analysed according to a sunburst diagram and a Sankey diagram.
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AstraZeneca
Lead sponsor
Hospitalidee
Collaborator
Hospitalidee has been asserted to be a valid organization name by UHToulouse
Collaborator