Status:
RECRUITING
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Pharmacyclics LLC.
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 reacti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 19 2029
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05963074
Start Date
May 30 2024
End Date
March 19 2029
Last Update
December 19 2025
Active Locations (74)
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1
The Oncology Institute Clinical Research
Cerritos, California, United States, 90703
2
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
3
SLO Oncology and Hematology Health Center
San Luis Obispo, California, United States, 93401
4
Providence Medical Foundation
Santa Rosa, California, United States, 95403