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

Running, not enrolling · Phase 2

Conditions studied: Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic Lymphoma

In brief

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).

Key facts

Study ID

NCT05963074

Run by

Janssen Research & Development, LLC

People needed

333

Starts

2024-05-30

Expected to finish

2029-03-19

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• The Oncology Institute Clinical Research — Cerritos, California, United States
• Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
• SLO Oncology and Hematology Health Center — San Luis Obispo, California, United States
• Providence Medical Foundation — Santa Rosa, California, United States
• PIH Health Hospital — Whittier, California, United States
• Grand Valley Oncology — Grand Junction, Colorado, United States
• Mount Sinai Medical Center Campus — Miami Beach, Florida, United States
• The Oncology Institute — North Miami Beach, Florida, United States
• Mid Florida Hematology Oncology — Orange, Florida, United States
• Boise VA Medical Center — Boise, Idaho, United States
• Hope and Healing Cancer Services — Hinsdale, Illinois, United States
• Springfield Clinic — Springfield, Illinois, United States
• Iowa City VA Health Care System — Iowa City, Iowa, United States
• Minnesota Oncology Hematology P A — Minneapolis, Minnesota, United States
• Research Medical Center — Kansas City, Missouri, United States
• Hunterdon Hematology Oncology — Flemington, New Jersey, United States
• Summit Medical Group — Florham Park, New Jersey, United States
• Hematology Oncology Associates of Rockland — Nyack, New York, United States
• Southeastern Medical Oncology Center — Goldsboro, North Carolina, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States
• OHSU Knight Cancer Institute — Portland, Oregon, United States
• Renovatio Clinical — El Paso, Texas, United States
• Texas Oncology-Fort Worth Cancer Center — Fort Worth, Texas, United States
• Fakultni nemocnice Olomouc — Olomouc, Czechia

Full record on ClinicalTrials.gov

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