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MEOI and HRQoL in CLL Patients Treated With BTKis

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04938141
Collaborator
(none)
260
Enrollment
16
Locations
24.2
Anticipated Duration (Months)
16.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-site observational study of medical events of interest (MEOI) and health-related quality of life (HRQoL) in chronic lymphocytic leukemia (CLL) patients initiating treatment with the Bruton's tyrosine kinase inhibitors (BTKi) acalabrutinib or ibrutinib in the United States (US).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    260 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Medical Events of Interest and Health-Related Quality of Life in Chronic Lymphocytic Leukemia Patients Initiating Treatment With Bruton's Tyrosine Kinase Inhibitors Acalabrutinib or Ibrutinib
    Actual Study Start Date :
    Oct 7, 2021
    Anticipated Primary Completion Date :
    Oct 15, 2023
    Anticipated Study Completion Date :
    Oct 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Acalabrutinib

    CLL patients initiating acalabrutinib alone or in combination with an anti-CD20 mAb
    Ibrutinib

    CLL patients receiving ibrutinib alone or in combination with an anti-CD20 mAb

    Outcome Measures

    Primary Outcome Measures

    1. Patient Characteristics [Baseline]

      To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.

    2. Chart Recorded Medical Events of Interest [24 Month Follow-up]

      To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using medical chart abstracted data, over a 24-month period

    3. Patient Reported Medical Events of Interest [24 month follow-up]

      To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period.

    4. HRQoL [24 month follow-up]

      To describe HRQoL for CLL patients who recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • ≥18 years old

    • Physician-confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL)

    • BTKi naïve patients who initiate acalabrutinib or ibrutinib treatment alone or in combination with an anti-CD20 mAb within 7 days (before or after) study enrollment*. Both treatment naïve and relapsed/refractory CLL patients will be included.

    • Provides informed consent

    • Adequate English reading skills

    • Able to access and use a computer, tablet, or smartphone to complete PROs

    Exclusion Criteria:

    • Use of BTKi any time prior to study enrollment.

    • Currently receiving systemic treatment for another malignancy

    • Currently enrolled in a clinical trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Fountain Valley California United States 92708
    2 Research Site Redlands California United States 92373
    3 Research Site Boca Raton Florida United States 33486
    4 Research Site Fort Lauderdale Florida United States 33308
    5 Research Site Saint Petersburg Florida United States 33709
    6 Research Site Tallahassee Florida United States 32308
    7 Research Site Tamarac Florida United States 33321
    8 Research Site Tampa Florida United States 33705-1407
    9 Research Site Savannah Georgia United States 31405
    10 Research Site Honolulu Hawaii United States 96813-5516
    11 Research Site Jackson Mississippi United States 39202
    12 Research Site Berkeley Heights New Jersey United States 07922
    13 Research Site Amherst New York United States 14228
    14 Research Site Charlotte North Carolina United States 27103
    15 Research Site Philadelphia Pennsylvania United States 19111
    16 Research Site York Pennsylvania United States 17403

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04938141
    Other Study ID Numbers:
    • D8220R00036
    First Posted:
    Jun 24, 2021
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Aug 19, 2022