Clinical trial NCT06125795: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Bruton Tyrosine Kinase Inhibitor
Patient-Reported Outcomes Measure
Patient-Reported Experience Measure
Venetoclax
Venclexta
Venclyxto
ABT-199
Patient Preferences
Cancer
PROVIDENCE
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-11-09
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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.

Primary outcomes:
measure: 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
timeFrame: Up to 27 Months
measure: Change in Participant Health-related Quality of Life (HRQoL)Measured Using the EORTC QLQ-C30 with the EORTC-CLL17 Supplement
timeFrame: Up to 27 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: HUA - Txagorritxu /ID# 258263
state: Alava
city: Gijón
country: Spain
facility: Hospital de Cabueñes /ID# 263307
state: Asturias
city: Manresa
country: Spain
facility: Sant Joan de Deu de Manresa /ID# 258266
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa /ID# 258267
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Hospital Jerez De La Frontera /ID# 258282
state: Cadiz
city: Laredo
country: Spain
facility: Hospital Comarcal de Laredo /ID# 258262
state: Cantabria
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 258261
state: Cantabria
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia /ID# 271507
state: Cordoba
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Dr. Negrin /ID# 258285
state: Las Palmas
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada /ID# 258275
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173
state: Murcia
city: Vigo
country: Spain
facility: Hospital Meixoeiro (CHUVI) /ID# 258286
state: Pontevedra
city: Galdakao
country: Spain
facility: Hospital Universitario de Galdakao /ID# 258264
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital de Sant Joan Despi Moises Broggi /ID# 262284
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 258280
city: Lugo
country: Spain
facility: Hospital Lucus Augusti /ID# 271542
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 258273
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 258269
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 258271
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 258270
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer /ID# 258284
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 258279
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: