Trial Title:
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
NCT ID:
NCT06125795
Condition:
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Conditions: 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
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HUA - Txagorritxu /ID# 258263
Address:
City:
Vitoria
Zip:
01009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital de Cabueñes /ID# 263307
Address:
City:
Gijón
Zip:
33394
Country:
Spain
Status:
Recruiting
Facility:
Name:
Sant Joan de Deu de Manresa /ID# 258266
Address:
City:
Manresa
Zip:
08243
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Mútua Terrassa /ID# 258267
Address:
City:
Terrassa
Zip:
08221
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Jerez de la Frontera /ID# 258282
Address:
City:
Jerez de la Frontera
Zip:
11407
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Comarcal de Laredo /ID# 258262
Address:
City:
Laredo
Zip:
39770
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marques de Valdecilla /ID# 258261
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Dr. Negrin /ID# 258285
Address:
City:
Las Palmas de Gran Canaria
Zip:
35019
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Fuenlabrada /ID# 258275
Address:
City:
Fuenlabrada
Zip:
28942
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173
Address:
City:
El Palmar
Zip:
30120
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Meixoeiro (CHUVI) /ID# 258286
Address:
City:
Vigo
Zip:
36213
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Galdakao /ID# 258264
Address:
City:
Galdakao
Zip:
48960
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital de Sant Joan Despi Moises Broggi /ID# 262284
Address:
City:
Barcelona
Zip:
08906
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen de las Nieves /ID# 258280
Address:
City:
Granada
Zip:
18014
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Maranon /ID# 258273
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz /ID# 258269
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre /ID# 258271
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario La Paz /ID# 258270
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Morales Meseguer /ID# 258284
Address:
City:
Murcia
Zip:
30008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Macarena /ID# 258279
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Start date:
November 6, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06125795
https://www.abbvieclinicaltrials.com/study/?id=P24-280
