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
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT06125795
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria:<br><br> - Have documented chronic lymphocytic leukemia (CLL) according to International<br> Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.<br><br> - Under oral treatment for CLL, either first-line or relapsed/refractory (R/R)<br> therapy.<br><br> - Treatment for CLL started 9 months (+/- 4 weeks) before inclusion for first-line<br> therapy or 21 months (+/- 4 weeks) before inclusion for R/R, under authorized<br> conditions.<br><br> - In the opinion of the investigator, cognitive ability to understand and answer the<br> questionnaires specified in the study protocol.<br><br> - Able to comply with the study protocol in the investigator's judgment.<br><br>Exclusion Criteria:<br><br> - Currently receiving any chemotherapy or chemoimmunotherapy.<br><br> - Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL) (Richter's<br> transformation or pro-lymphocytic leukaemia).<br><br> - Currently participating in interventional research (not including non-interventional<br> study, post-marketing observational study, or registry participation).<br><br> - Any serious medical condition or abnormality in clinical laboratory tests that, in<br> the investigator's judgment, precludes the participant's safe participation in and<br> completion of the study.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Participant Functioning Measured Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the EORTC Chronic Lymphocytic Leukemia 17 (EORTC-CLL17) Supplement;Change in Participant Health-related Quality of Life (HRQoL)Measured Using the EORTC QLQ-C30 with the EORTC-CLL17 Supplement
- Secondary Outcome Measures
Name Time Method