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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jul 19, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how effective and safe a combination treatment of ibrutinib and venetoclax is, compared to using ibrutinib alone, for patients with chronic lymphocytic leukemia (CLL) who haven't received treatment before. The study aims to customize the dosing of ibrutinib based on how patients respond to the treatment and any side effects they may experience. Researchers want to find the best way to manage the medication to help patients feel better and improve their condition.

To participate in this trial, individuals must have a confirmed diagnosis of CLL or small lymphocytic lymphoma and meet certain health criteria, such as having a specific level of health status (measured by the ECOG scale) and measurable disease based on imaging scans. Participants should expect to attend regular check-ups to monitor their health and response to treatment. It's important to note that participants must agree to certain precautions, such as not becoming pregnant during the study. This trial is currently recruiting patients, so those interested should talk to their doctor to see if they qualify.

Gender

ALL

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, 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