MEOI and HRQoL in CLL Patients Treated With BTKis
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
1 other identifier
observational
23
1 country
16
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2021
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedStudy Start
First participant enrolled
October 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2024
CompletedMay 21, 2025
April 1, 2025
3 years
June 17, 2021
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Patient Characteristics
To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.
Baseline
Chart Recorded Medical Events of Interest
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
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
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
Study Arms (2)
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
Eligibility Criteria
Adult patients who have recently initiated treatment for CLL/SLL with acalabrutinib or ibrutinib in the front-line or relapsed/refractory setting
You may qualify if:
- ≥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
You may not qualify if:
- Use of BTKi any time prior to study enrollment.
- Currently receiving systemic treatment for another malignancy
- Currently enrolled in a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Research Site
Fountain Valley, California, 92708, United States
Research Site
Redlands, California, 92373, United States
Research Site
Boca Raton, Florida, 33486, United States
Research Site
Fort Lauderdale, Florida, 33308, United States
Research Site
St. Petersburg, Florida, 33709, United States
Research Site
Tallahassee, Florida, 32308, United States
Research Site
Tamarac, Florida, 33321, United States
Research Site
Tampa, Florida, 33705-1407, United States
Research Site
Savannah, Georgia, 31405, United States
Research Site
Honolulu, Hawaii, 96813-5516, United States
Research Site
Jackson, Mississippi, 39202, United States
Research Site
Berkeley Heights, New Jersey, 07922, United States
Research Site
Amherst, New York, 14228, United States
Research Site
Charlotte, North Carolina, 27103, United States
Research Site
Philadelphia, Pennsylvania, 19111, United States
Research Site
York, Pennsylvania, 17403, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2021
First Posted
June 24, 2021
Study Start
October 7, 2021
Primary Completion
September 26, 2024
Study Completion
September 26, 2024
Last Updated
May 21, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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