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
Chronic lymphocytic leukemia (CLL) is the most common leukemia in the Western world. Since in most cases CLL remains an incurable disease, the goals of therapy are to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Spain.
Study participants will receive oral treatments for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments will be enrolled. Around 132 participants will be enrolled in the study in sites in Spain.
Participants will receive oral treatments for CLL according to the approved local label. The overall study duration will be 18 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Participant Health-related Quality of Life (HRQoL)Measured Using the EORTC QLQ-C30 with the EORTC-CLL17 Supplement Up to 27 Months The EORTC-CLL17 is a specific questionnaire that supplements the EORTC QLQ-C30 for participants with CLL.
EORTC-CLL17 comprises 17 items divided into three subscales: symptom burden, physical condition/fatigue, and worries/fears about the health and functioning. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. A high score represents a high level of symptomology high level of physical condition/fatigue, and a high level of worries/fears about the health and functioning.
EORTC QLQ-C30 is a questionnaire to assess the QoL of cancer participants. It is composed of five functional scales, three symptom scales, a global health status/QoL scale, and six single items. A high score represents a high level of functioning, or QoL, but a high level of symptomology/problems.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 Up to 27 Months The EORTC-CLL17 is a specific questionnaire that supplements the EORTC QLQ-C30 for participants with CLL.
EORTC-CLL17 comprises 17 items divided into three subscales: symptom burden, physical condition/fatigue, and worries/fears about the health and functioning. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. A high score represents a high level of symptomology high level of physical condition/fatigue, and a high level of worries/fears about the health and functioning.
EORTC QLQ-C30 is a questionnaire to assess the quality of life (QoL) of cancer participants. It is composed of five functional scales, three symptom scales, a global health status/QoL scale, and six single items. A high score represents high level of functioning, or QoL, but a high level of symptomology/problems.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Hospital Jerez De La Frontera /ID# 258282
🇪🇸Jerez de la Frontera, Cadiz, Spain
Hospital Universitario Reina Sofia /ID# 271507
🇪🇸Córdoba, Cordoba, Spain
Hospital Lucus Augusti /ID# 271542
🇪🇸Lugo, Spain
HUA - Txagorritxu /ID# 258263
🇪🇸Vitoria, Alava, Spain
Hospital de Cabueñes /ID# 263307
🇪🇸Gijón, Asturias, Spain
Sant Joan de Deu de Manresa /ID# 258266
🇪🇸Manresa, Barcelona, Spain
Hospital Universitari Mútua Terrassa /ID# 258267
🇪🇸Terrassa, Barcelona, Spain
Hospital Comarcal de Laredo /ID# 258262
🇪🇸Laredo, Cantabria, Spain
Hospital Universitario Marques de Valdecilla /ID# 258261
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Dr. Negrin /ID# 258285
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario de Fuenlabrada /ID# 258275
🇪🇸Fuenlabrada, Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173
🇪🇸El Palmar, Murcia, Spain
Hospital Meixoeiro (CHUVI) /ID# 258286
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario de Galdakao /ID# 258264
🇪🇸Galdakao, Vizcaya, Spain
Hospital de Sant Joan Despi Moises Broggi /ID# 262284
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de las Nieves /ID# 258280
🇪🇸Granada, Spain
Hospital General Universitario Gregorio Maranon /ID# 258273
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 258269
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 258271
🇪🇸Madrid, Spain
Hospital Universitario La Paz /ID# 258270
🇪🇸Madrid, Spain
Hospital General Universitario Morales Meseguer /ID# 258284
🇪🇸Murcia, Spain
Hospital Universitario Virgen Macarena /ID# 258279
🇪🇸Sevilla, Spain