NCT05963074

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

Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib capsules will be administered orally.
DRUG	Venetoclax	Venetoclax tablets will be administered orally.

Timeline

• Start date: 2024-05-30
• Primary completion: 2027-12-15
• Completion: 2029-03-19
• First posted: 2023-07-27
• Last updated: 2026-04-13

Locations

73 sites across 8 countries: United States, Canada, Czechia, France, Hungary, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study