drugset / Trial / NCT05963074

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

NCT05963074

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

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 280 mg Oral
Subject Ibrutinib Small molecule 420 mg Oral
Subject Venetoclax Small molecule 400 mg Oral