Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Acalabrutinib
- description
- CLL patients initiating acalabrutinib alone or in combination with an anti-CD20 mAb
- label
- Ibrutinib
- description
- CLL patients receiving ibrutinib alone or in combination with an anti-CD20 mAb
Primary outcomes (4)
- measure
- Patient Characteristics
- timeFrame
- Baseline
- description
- To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.
- measure
- Chart Recorded Medical Events of Interest
- timeFrame
- 24 Month Follow-up
- description
- To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using medical chart abstracted data, over a 24-month period
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available