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
PROVIDENCE
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
1 other identifier
observational
146
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2023
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2023
CompletedStudy Start
First participant enrolled
November 6, 2023
CompletedFirst Posted
Study publicly available on registry
November 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
CompletedMay 1, 2026
April 1, 2026
2.7 years
October 24, 2023
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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.
Up to 27 Months
Change in Participant Health-related Quality of Life (HRQoL)Measured Using the EORTC QLQ-C30 with the EORTC-CLL17 Supplement
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.
Up to 27 Months
Study Arms (1)
Chronic Lymphocytic Leukemia (CLL) Participants
Participants will receive oral treatments for CLL in accordance with approved local label.
Eligibility Criteria
Adult participants diagnosed with chronic lymphocytic leukemia (CLL) treated with fixed-time duration (FTD) or continuous oral regimens who attend to a regular follow up visit at a Spanish participating hospital will be eligible to participate in the study.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (25)
HUA - Txagorritxu /ID# 258263
Vitoria-Gasteiz, Alava, 01009, Spain
Sant Joan de Deu de Manresa /ID# 258266
Manresa, Barcelona, 08423, Spain
Hospital Universitari Mútua Terrassa /ID# 258267
Terrassa, Barcelona, 08221, Spain
Hospital Jerez De La Frontera /ID# 258282
Jerez de la Frontera, Cadiz, 11407, Spain
Hospital Comarcal de Laredo /ID# 258262
Laredo, Cantabria, 39770, Spain
Hospital Universitario Marques de Valdecilla /ID# 258261
Santander, Cantabria, 39008, Spain
Hospital Universitario Dr. Negrin /ID# 258285
Las Palmas de Gran Canaria, Las Palmas, 35019, Spain
Hospital Universitario de León /ID# 271526
León, Leon, 24080, Spain
Hospital Universitario de Fuenlabrada /ID# 258275
Fuenlabrada, Madrid, 28942, Spain
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173
El Palmar, Murcia, 30120, Spain
Hospital Meixoeiro (CHUVI) /ID# 258286
Vigo, Pontevedra, 36213, Spain
Hospital de Cabuenes /ID# 263307
Gijón, Principality of Asturias, 33394, Spain
Hospital Universitario Central de Asturias /ID# 271508
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitario de Galdakao /ID# 258264
Galdakao, Vizcaya, 48960, Spain
Hospital de Sant Joan Despi Moises Broggi /ID# 262284
Barcelona, 08906, Spain
Hospital Universitario Reina Sofia /ID# 271507
Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves /ID# 258280
Granada, 18014, Spain
Hospital Lucus Augusti /ID# 271542
Lugo, 27004, Spain
Hospital Universitario de La Princesa /ID# 271506
Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon /ID# 258273
Madrid, 28007, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 258269
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre /ID# 258271
Madrid, 28041, Spain
Hospital Universitario La Paz /ID# 258270
Madrid, 28046, Spain
Hospital General Universitario Morales Meseguer /ID# 258284
Murcia, 30008, Spain
Hospital Universitario Virgen Macarena /ID# 258279
Seville, 41009, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2023
First Posted
November 9, 2023
Study Start
November 6, 2023
Primary Completion
July 1, 2026
Study Completion
July 1, 2026
Last Updated
May 1, 2026
Record last verified: 2026-04