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)

April 30, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08906
        • Hospital de Sant Joan Despi Moises Broggi /ID# 262284
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia /ID# 271507
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves /ID# 258280
      • Lugo, Spain, 27004
        • Hospital Lucus Augusti /ID# 271542
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa /ID# 271506
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon /ID# 258273
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 258269
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 258271
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz /ID# 258270
      • Murcia, Spain, 30008
        • Hospital General Universitario Morales Meseguer /ID# 258284
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena /ID# 258279
    • Alava
      • Vitoria-Gasteiz, Alava, Spain, 01009
        • HUA - Txagorritxu /ID# 258263
    • Barcelona
      • Manresa, Barcelona, Spain, 08423
        • Sant Joan de Deu de Manresa /ID# 258266
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mútua Terrassa /ID# 258267
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spain, 11407
        • Hospital Jerez De La Frontera /ID# 258282
    • Cantabria
      • Laredo, Cantabria, Spain, 39770
        • Hospital Comarcal de Laredo /ID# 258262
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla /ID# 258261
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
        • Hospital Universitario Dr. Negrin /ID# 258285
    • Leon
      • León, Leon, Spain, 24080
        • Hospital Universitario de León /ID# 271526
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada /ID# 258275
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Hospital Meixoeiro (CHUVI) /ID# 258286
    • Principality of Asturias
      • Gijón, Principality of Asturias, Spain, 33394
        • Hospital de Cabuenes /ID# 263307
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias /ID# 271508
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital Universitario de Galdakao /ID# 258264

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Lymphocytic Leukemia (CLL) Participants
Participants will receive oral treatments for CLL in accordance with approved local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Up to 27 Months
Change in Participant Health-related Quality of Life (HRQoL)Measured Using the EORTC QLQ-C30 with the EORTC-CLL17 Supplement
Time Frame: 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.
Up to 27 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P24-280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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