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Recruiting Phase 2 NCT05963074

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

Trial Parameters

Condition Leukemia, Lymphocytic, Chronic, B-Cell
Sponsor Janssen Research & Development, LLC
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 320
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-05-30
Completion 2027-12-15
Interventions
IbrutinibVenetoclax

Brief 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 Criteria

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 additional contraceptive method * A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or until 1 month after last dose or per local label if more conservative (for example, 3 months in European Union or Canada and 1 month in United States) Exclusion Criteria: * Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura

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