drugset / Trial / NCT05963074
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).
Timeline
- Start
- 2024-05-30
- Primary completion
- 2027-12-15
- Completion
- 2029-03-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 280 mg | Oral |
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |