Assessing health and quality of life in adults with chronic lymphocytic leukemia in Spain
Non-interventional Prospective Descriptive Study to Assess the Impact on Patient´s Well-being of Fixed-time Duration (FTD) and Continuous Oral Regimens for Newly Diagnosed and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice in Spain
This study is trying to understand how living with chronic lymphocytic leukemia affects the health and quality of life of adults in Spain who are getting oral treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 22 sites (Vitoria, Alava and 21 other locations) |
| Trial ID | NCT06125795 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the health-related quality of life and functioning of adult participants diagnosed with chronic lymphocytic leukemia (CLL) who are receiving oral treatments in routine clinical practice across various sites in Spain. Participants will be enrolled based on their treatment history and will complete questionnaires to report their experiences and outcomes related to CLL. The study aims to gather data over an 18-month period without imposing additional burdens on participants, as all visits will occur during standard clinical care.
Who should consider this trial
Good fit: Ideal candidates include adults with documented chronic lymphocytic leukemia who are currently receiving oral treatments.
Not a fit: Patients undergoing chemotherapy or those with aggressive transformations of CLL may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the quality of life and treatment experiences of CLL patients, potentially guiding future therapeutic approaches.
How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have successfully highlighted patient-reported outcomes in chronic conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vitoria, Alava and 21 other locations
- HUA - Txagorritxu /ID# 258263 — Vitoria, Alava, Spain (Recruiting)
- Hospital de Cabueñes /ID# 263307 — Gijón, Asturias, Spain (Recruiting)
- Sant Joan de Deu de Manresa /ID# 258266 — Manresa, Barcelona, Spain (Recruiting)
- Hospital Universitari Mútua Terrassa /ID# 258267 — Terrassa, Barcelona, Spain (Recruiting)
- Hospital Jerez De La Frontera /ID# 258282 — Jerez de la Frontera, Cadiz, Spain (Recruiting)
- Hospital Comarcal de Laredo /ID# 258262 — Laredo, Cantabria, Spain (Recruiting)
- Hospital Universitario Marques de Valdecilla /ID# 258261 — Santander, Cantabria, Spain (Recruiting)
- Hospital Universitario Reina Sofia /ID# 271507 — Córdoba, Cordoba, Spain (Recruiting)
- Hospital Universitario Dr. Negrin /ID# 258285 — Las Palmas de Gran Canaria, Las Palmas, Spain (Recruiting)
- Hospital Universitario de Fuenlabrada /ID# 258275 — Fuenlabrada, Madrid, Spain (Recruiting)
- Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173 — El Palmar, Murcia, Spain (Recruiting)
- Hospital Meixoeiro (CHUVI) /ID# 258286 — Vigo, Pontevedra, Spain (Recruiting)
- Hospital Universitario de Galdakao /ID# 258264 — Galdakao, Vizcaya, Spain (Recruiting)
- Hospital de Sant Joan Despi Moises Broggi /ID# 262284 — Barcelona, Spain (Recruiting)
- Hospital Universitario Virgen de las Nieves /ID# 258280 — Granada, Spain (Recruiting)
- Hospital Lucus Augusti /ID# 271542 — Lugo, Spain (Recruiting)
- Hospital General Universitario Gregorio Maranon /ID# 258273 — Madrid, Spain (Recruiting)
- Hospital Universitario Fundacion Jimenez Diaz /ID# 258269 — Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre /ID# 258271 — Madrid, Spain (Recruiting)
- Hospital Universitario La Paz /ID# 258270 — Madrid, Spain (Recruiting)
- Hospital General Universitario Morales Meseguer /ID# 258284 — Murcia, Spain (Recruiting)
- Hospital Universitario Virgen Macarena /ID# 258279 — Sevilla, Spain (Recruiting)
Study contacts
- Study coordinator: AbbVie Spain Medical Info iKnow
- Email: medical_info_spain@abbvie.com
- Phone: +34 913-343-922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.