MEOI and HRQoL in CLL Patients Treated With BTKis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-07

Study Completion Date

2024-09-26

Brief Summary

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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)

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Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acalabrutinib

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

No interventions assigned to this group

Ibrutinib

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

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No