Chronic Lymphocytic LeukemiaPROVIDENCENCT06125795
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
An observational study of Chronic Lymphocytic Leukemia, run by AbbVie at 25 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- Type of treatment
- Pill or oral medicine
- How many people
- 146 participants
- Where
- 25 sitesSpain
- Study dates
- 6 Nov 2023to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Hospital de Sant Joan Despi Moises Broggi /ID# 262284
Barcelona, 08906
Hospital Universitario Reina Sofia /ID# 271507
Córdoba, 14004
Hospital Clinico Universitario Virgen de la Arrixaca /ID# 262173
El Palmar, Murcia, 30120
Hospital Universitario de Fuenlabrada /ID# 258275
Fuenlabrada, Madrid, 28942
Hospital Universitario de Galdakao /ID# 258264
Galdakao, Vizcaya, 48960
Hospital de Cabuenes /ID# 263307
Gijón, Principality of Asturias, 33394
Hospital Universitario Virgen de las Nieves /ID# 258280
Granada, 18014
Hospital Jerez De La Frontera /ID# 258282
Jerez de la Frontera, Cadiz, 11407
Hospital Comarcal de Laredo /ID# 258262
Laredo, Cantabria, 39770
Hospital Universitario Dr. Negrin /ID# 258285
Las Palmas de Gran Canaria, Las Palmas, 35019
Hospital Universitario de León /ID# 271526
León, Leon, 24080
Hospital Lucus Augusti /ID# 271542
Lugo, 27004
Hospital Universitario de La Princesa /ID# 271506
Madrid, 28006
Hospital General Universitario Gregorio Maranon /ID# 258273
Madrid, 28007
Hospital Universitario Fundacion Jimenez Diaz /ID# 258269
Madrid, 28040
Hospital Universitario 12 de Octubre /ID# 258271
Madrid, 28041
Hospital Universitario La Paz /ID# 258270
Madrid, 28046
Sant Joan de Deu de Manresa /ID# 258266
Manresa, Barcelona, 08423
Hospital General Universitario Morales Meseguer /ID# 258284
Murcia, 30008
Hospital Universitario Central de Asturias /ID# 271508
Oviedo, Principality of Asturias, 33011
Hospital Universitario Marques de Valdecilla /ID# 258261
Santander, Cantabria, 39008
Hospital Universitario Virgen Macarena /ID# 258279
Seville, 41009
Hospital Universitari Mútua Terrassa /ID# 258267
Terrassa, Barcelona, 08221
Hospital Meixoeiro (CHUVI) /ID# 258286
Vigo, Pontevedra, 36213
HUA - Txagorritxu /ID# 258263
Vitoria-Gasteiz, Alava, 01009
About this study
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
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.
Read more
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.
- 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
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Patient Preference, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) Participants | Participants will receive oral treatments for CLL in accordance with approved local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 27 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start6 Nov 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125795
- Sponsor's protocol ID
- P24-280
- Acronym
- PROVIDENCE
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06125795
- Acronym / sponsor ID
- PROVIDENCE / P24-280
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) Participants | – | –Participants will receive oral treatments for CLL in accordance with approved local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by AbbVie at 25 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 27 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.