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)

AbbVie

Status: Enrolling

Conditions: Chronic Lymphocytic Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT06125795

P24-280

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

132 participants in 1 patient group

Chronic Lymphocytic Leukemia (CLL) Participants

Description:

Participants will receive oral treatments for CLL in accordance with approved local label.