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

Chronic Lymphocytic Leukemia Clinical Trial

— PROVIDENCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125795
• Other study ID #: P24-280
• Status: Recruiting
• Start date: November 6, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: AbbVie Spain Medical Info iKnow
• Phone: +34 913-343-922
• Email: medical_info_spain[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Spain	Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173	El Palmar	Murcia
Spain	Hospital Universitario de Fuenlabrada /ID# 258275	Fuenlabrada	Madrid
Spain	Hospital Universitario de Galdakao /ID# 258264	Galdakao	Vizcaya
Spain	Hospital Universitario Virgen de las Nieves /ID# 258280	Granada
Spain	Hospital Universitario de Jerez de la Frontera /ID# 258282	Jerez de la Frontera	Cadiz
Spain	Hospital Comarcal de Laredo /ID# 258262	Laredo	Cantabria
Spain	Hospital Universitario Dr. Negrin /ID# 258285	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital General Universitario Gregorio Maranon /ID# 258273	Madrid
Spain	Hospital Universitario 12 de Octubre /ID# 258271	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 258269	Madrid
Spain	Hospital Universitario La Paz /ID# 258270	Madrid
Spain	Sant Joan de Deu de Manresa /ID# 258266	Manresa	Barcelona
Spain	Hospital General Universitario Morales Meseguer /ID# 258284	Murcia
Spain	Hospital Universitario Marques de Valdecilla /ID# 258261	Santander	Cantabria
Spain	Hospital Universitario Virgen Macarena /ID# 258279	Sevilla
Spain	Hospital Universitari Mútua Terrassa /ID# 258267	Terrassa	Barcelona
Spain	Hospital Meixoeiro (CHUVI) /ID# 258286	Vigo	Pontevedra
Spain	HUA - Txagorritxu /ID# 258263	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

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