A Study to Assess Change in Functioning and Health Related Quality of Life in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Treatments in Routine Clinical Practice in Spain

Launched by ABBVIE · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well adult patients with chronic lymphocytic leukemia (CLL) are doing while receiving oral treatments in everyday healthcare settings in Spain. CLL is a type of blood cancer that is common in Western countries and, while it often can't be cured, treatments aim to improve patients' quality of life and help them live longer. The study will follow about 132 participants who are already on approved oral medications for CLL, either as their first treatment or after previous treatments have not worked.

To be eligible for this study, participants need to have a confirmed diagnosis of CLL and should be undergoing oral treatment that started within certain time frames. Participants should also be able to understand and complete some questionnaires about their health. The study is designed to fit into regular doctor visits, so there won't be any extra demands on participants' time. Overall, the trial will last for 18 months, and it aims to better understand how people feel and function while receiving these treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have documented chronic lymphocytic leukemia (CLL) according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
• • Under oral treatment for CLL, either first-line or relapsed/refractory (R/R) therapy.
• • Treatment for CLL started 9 months (+/- 4 weeks) before inclusion for first-line therapy or 21 months (+/- 4 weeks) before inclusion for R/R, under authorized conditions.
• • In the opinion of the investigator, cognitive ability to understand and answer the questionnaires specified in the study protocol.
• • Able to comply with the study protocol in the investigator's judgment.
• Exclusion Criteria:
• • Currently receiving any chemotherapy or chemoimmunotherapy.
• • Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukaemia).
• • Currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation).
• • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.