Chronic Lymphocytic Leukemia Clinical Trial
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
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 leukemia-cll/" >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
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There are 22 Locations for this study
Cerritos California, 90703, United States
Santa Rosa California, 95403, United States
Whittier California, 90602, United States
Grand Junction Colorado, 81505, United States
Miami Beach Florida, 33140, United States
Hinsdale Illinois, 60521, United States
Springfield Illinois, 62702, United States
Iowa City Iowa, 52246, United States
Minneapolis Minnesota, 55404, United States
Kansas City Missouri, 64132, United States
Flemington New Jersey, 08822, United States
Goldsboro North Carolina, 27534, United States
Cincinnati Ohio, 45242, United States
Eugene Oregon, 97401, United States
Fort Worth Texas, 76104, United States
The Woodlands Texas, 77380, United States
Ogden Utah, 84405, United States
Gainesville Virginia, 20155, United States
Virginia Beach Virginia, 23456, United States
Seattle Washington, 98108, United States
Vancouver Washington, 98684, United States
Santander , 39008, Spain
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