Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 168
- Primary Endpoint
- Percentage of Participants Achieving Best Overall Response Rate (ORR)
Study Overview
Brief Summary
An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed at the discretion of the physician and in accordance with local clinical practice and label.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Participant with chronic lymphocytic leukemia (CLL) who start venetoclax therapy can be included in the study if treated as specified in the local label for any specific line of treatment.
Exclusion Criteria
- Not provided
Arms & Interventions
Participants Receiving Venetoclax + Ibrutinib
Participants with CLL receiving venetoclax in combination with ibrutinib.
Participants Receiving Venetoclax + Acalabrutinib
Participants with CLL receiving venetoclax in combination with acalabrutinib.
Participants Receiving Venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
Participants Receiving Venetoclax + Rituximab
Participants with CLL receiving venetoclax in combination with rituximab.
Participants Receiving Venetoclax + Obinutuzumab
Participants with CLL receiving venetoclax in combination with obinutuzumab.
Outcomes
Primary Outcomes
Percentage of Participants Achieving Best Overall Response Rate (ORR)
Time Frame: Up to 12 months
ORR is defined as the percentage of participants achieving partial response (PR) and complete response with incomplete regeneration of bone marrow (CRi) and complete response (CR) according to physician's assessment to therapy with venetoclax.
Secondary Outcomes
No secondary outcomes reported