Clinical trial NCT04938141: MEOI and HRQoL in CLL Patients Treated With BTKis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-06-24
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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)


Eligibility criteria: 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

Primary outcomes:
measure: Patient Characteristics
timeFrame: Baseline
measure: Chart Recorded Medical Events of Interest
timeFrame: 24 Month Follow-up
measure: Patient Reported Medical Events of Interest
timeFrame: 24 month follow-up
measure: HRQoL
timeFrame: 24 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Redlands
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Tamarac
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: Berkeley Heights
country: United States
facility: Research Site
state: New Jersey
city: Amherst
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: York
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
References: