OBJECTIVES: Established quality of life (QoL) assessments report little detail around the patient’s treatment experience. This study addresses this knowledge gap utilizing a unique mixed-methods approach to provide novel patient-centric data regarding the real-world treatment-related experience and QoL of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) on second-line fixed-duration (venetoclax, in combination with rituximab [Ven+R]) or continuous treatments (ibrutinib and acalabrutinib; Bruton’s tyrosine kinase inhibitors [BTKis]).

METHODS: This is a non-interventional, mixed-methods study utilizing qualitative interviews and a retrospective chart review. The cohort will consist of 140 eligible patients with R/R CLL that have been prescribed Ven+R (n=80) or a BTKi (acalabrutinib or ibrutinib; n=60) as second-line treatment after first-line treatment with chemotherapy or chemoimmunotherapy (patients that received first-line BTKi or Venetoclax are excluded). Patients are stratified within treatment groups by time since treatment initiation. Interviewers use a semi-structured guide developed collaboratively with CLL Support (patient-led UK Charity) to conduct interviews.

Key interview themes include: impact of treatment on the patient (QoL, controlling symptoms, ability to perform everyday tasks, attitudes and treatment effects throughout treatment journey), the patient’s experience starting treatment (involvement in treatment decision, understanding of deep response, information explained to them prior to treatment initiation), patient experience at prespecified timepoints (capture treatment initiation, on/off treatment periods), and patient perspective of treatment duration (patient feelings/attitudes to completing treatment, impact on life after completing treatment). Retrospective medical record-based data collection will supplement the qualitative data. All analysis will be descriptive. Ethical approval was gained in October 2022, results planned late 2023.

RESULTS: As of May 2023, n=51/140 patients have been recruited; 18 had been prescribed a BTKi and 32 prescribed Ven+R.

CONCLUSIONS: By employing rigorous qualitative and mixed-methods approaches, this study will provide novel real-world evidence on the patient experience and support the treatment decisions of healthcare professionals and patients with R/R CLL.