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).

View Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

320

Study ID:

NCT05963074

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 16 Locations for this study

See Locations Near You

The Oncology Institute Clinical Research
Cerritos California, 90703, United States
Providence Medical Foundation
Santa Rosa California, 95403, United States
PIH Health Hospital
Whittier California, 90602, United States
Grand Valley Oncology
Grand Junction Colorado, 81505, United States
Hope and Healing Cancer Services
Hinsdale Illinois, 60521, United States
Minnesota Oncology Hematology, P.A.
Minneapolis Minnesota, 55404, United States
Hunterdon Hematology Oncology
Flemington New Jersey, 08822, United States
Oncology Hematology Care
Cincinnati Ohio, 45242, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth Texas, 76104, United States
Texas Oncology-Gulf Coast
The Woodlands Texas, 77380, United States
Community Cancer Trials of Utah
Ogden Utah, 84405, United States
Virginia Cancer Specialists
Gainesville Virginia, 20155, United States
Virginia Oncology Associates
Virginia Beach Virginia, 23456, United States
VA Puget Sound Healthcare System
Seattle Washington, 98108, United States
Northwest Cancer Specialists PC
Vancouver Washington, 98684, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

320

Study ID:

NCT05963074

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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