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


Description

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).

Trial Eligibility

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, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone greater than (\>) 20 milligrams (mg) daily (or corticosteroid equivalent) to treat or control the autoimmune disease * Known bleeding disorders (example, von Willebrand's disease or hemophilia) * Stroke or intracranial hemorrhage within 6 months prior to enrollment * Known or suspected Richter's transformation or central nervous system (CNS) involvement * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class II, III, or IV congestive heart failure as defined by the New York Heart Association Functional Classification

Study Info

Organization

Janssen Research & Development, LLC


Primary Outcome

Best Overall Response Rate (ORR)


Outcome Timeframe Up to 5 years

NCTID NCT05963074

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2024-01-31

Completion Date 2028-09-29

Enrollment Target 320

Interventions

DRUG Ibrutinib

DRUG Venetoclax

Locations Recruiting

The Oncology Institute Clinical Research

United States, California, Cerritos


SLO Oncology and Hematology Health Center

United States, California, San Luis Obispo


Providence Medical Foundation

United States, California, Santa Rosa


PIH Health Hospital

United States, California, Whittier


Grand Valley Oncology

United States, Colorado, Grand Junction


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