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

Description

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).

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic Lymphoma

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Study Overview

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Study Details

Study overview

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).

Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia

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

Condition
Leukemia, Lymphocytic, Chronic, B-Cell
Intervention / Treatment

-

Contacts and Locations

Cerritos

The Oncology Institute Clinical Research, Cerritos, California, United States, 90703

Los Alamitos

Cancer and Blood Specialty Clinic, Los Alamitos, California, United States, 90720

San Luis Obispo

SLO Oncology and Hematology Health Center, San Luis Obispo, California, United States, 93401

Santa Rosa

Providence Medical Foundation, Santa Rosa, California, United States, 95403

Whittier

PIH Health Hospital, Whittier, California, United States, 90602

Grand Junction

Grand Valley Oncology, Grand Junction, Colorado, United States, 81505

Miami Beach

Mount Sinai Medical Center Campus, Miami Beach, Florida, United States, 33140-2948

North Miami Beach

The Oncology Institute, North Miami Beach, Florida, United States, 33169

Boise

Boise VA Medical Center, Boise, Idaho, United States, 83702

Hinsdale

Hope and Healing Cancer Services, Hinsdale, Illinois, United States, 60521

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2029-03-19