MEOI and HRQoL in CLL Patients Treated With BTKis

May 20, 2025 updated by: AstraZeneca

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

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)

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

23

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

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Research Site
      • Redlands, California, United States, 92373
        • Research Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Research Site
      • Fort Lauderdale, Florida, United States, 33308
        • Research Site
      • Saint Petersburg, Florida, United States, 33709
        • Research Site
      • Tallahassee, Florida, United States, 32308
        • Research Site
      • Tamarac, Florida, United States, 33321
        • Research Site
      • Tampa, Florida, United States, 33705-1407
        • Research Site
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813-5516
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Research Site
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Research Site
    • New York
      • Amherst, New York, United States, 14228
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 27103
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Research Site
      • York, Pennsylvania, United States, 17403
        • Research Site

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients who have recently initiated treatment for CLL/SLL with acalabrutinib or ibrutinib in the front-line or relapsed/refractory setting

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Characteristics
Time Frame: Baseline
To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.
Baseline
Chart Recorded Medical Events of Interest
Time Frame: 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
24 Month Follow-up
Patient Reported Medical Events of Interest
Time Frame: 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.
24 month follow-up
HRQoL
Time Frame: 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
24 month follow-up

Collaborators and Investigators

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

Sponsor

AstraZeneca

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)

October 7, 2021

Primary Completion (Actual)

September 26, 2024

Study Completion (Actual)

September 26, 2024

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8220R00036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal

Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

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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