Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia
Janssen Research & Development, LLC
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria * For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2 * Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (\>=) 1.5 centimeters (cm) in longest diameter * A participant using oral contraceptives must use an addition…
Interventions
- DrugIbrutinib
Ibrutinib capsules will be administered orally.
- DrugVenetoclax
Venetoclax tablets will be administered orally.
Locations (73)
- The Oncology Institute Clinical ResearchCerritos, California
- Cancer and Blood Specialty ClinicLos Alamitos, California
- SLO Oncology and Hematology Health CenterSan Luis Obispo, California
- Providence Medical FoundationSanta Rosa, California
- PIH Health HospitalWhittier, California
- Grand Valley OncologyGrand Junction, Colorado