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

Study Identifier
P24-280
CT.gov Identifier
NCT06125795
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    HUA - Txagorritxu /ID# 258263
    Vitoria-Gasteiz, Alava, Spain, 01009
    Status
    Not applicable
    Location
    Sant Joan de Deu de Manresa /ID# 258266
    Manresa, Barcelona, Spain, 08423
    Status
    Not applicable
    Location
    Hospital Universitari Mútua Terrassa /ID# 258267
    Terrassa, Barcelona, Spain, 08221
    Status
    Not applicable
    Location
    Hospital Jerez De La Frontera /ID# 258282
    Jerez de la Frontera, Cadiz, Spain, 11407
    Status
    Not applicable
    Location
    Hospital Comarcal de Laredo /ID# 258262
    Laredo, Cantabria, Spain, 39770
    Status
    Not applicable
    Location
    Hospital Universitario Marques de Valdecilla /ID# 258261
    Santander, Cantabria, Spain, 39008
    Status
    Not applicable
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