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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax 		Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15.
  • Drug: Ibrutinib
    Ibrutinib capsules will be administered orally.
    Other names:
    • JNJ-54179060, IMBRUVICA
  • Drug: Venetoclax
    Venetoclax tablets will be administered orally.
    Other names:
    • VENCLEXTA, VENCLYXTO
Experimental
Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax 		Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15.
  • Drug: Ibrutinib
    Ibrutinib capsules will be administered orally.
    Other names:
    • JNJ-54179060, IMBRUVICA
  • Drug: Venetoclax
    Venetoclax tablets will be administered orally.
    Other names:
    • VENCLEXTA, VENCLYXTO
Experimental
Cohort 2a: Continuous Ibrutinib Monotherapy 		Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.
  • Drug: Ibrutinib
    Ibrutinib capsules will be administered orally.
    Other names:
    • JNJ-54179060, IMBRUVICA
Experimental
Cohort 2b: Continuous Ibrutinib Monotherapy 		Participants will receive ibrutinib 420 mg QD for 1 cycle (1 cycle = 28 days) followed by Ibrutinib 280 mg QD (or last tolerated dose) and continue until disease progression or unacceptable toxicity.
  • Drug: Ibrutinib
    Ibrutinib capsules will be administered orally.
    Other names:
    • JNJ-54179060, IMBRUVICA

Recruiting Locations

The Oncology Institute Clinical Research
Cerritos, California 90703

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

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

Providence Medical Foundation
Santa Rosa, California 95403

PIH Health Hospital
Whittier, California 90602

Grand Valley Oncology
Grand Junction, Colorado 81505

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

The Oncology Institute
North Miami Beach, Florida 33169

Mid Florida Hematology Oncology
Orange, Florida 32763

Boise VA Medical Center
Boise, Idaho 83702

Hope and Healing Cancer Services
Hinsdale, Illinois 60521

Springfield Clinic
Springfield, Illinois 62702

Iowa City VA Health Care System
Iowa City, Iowa 52246

Minnesota Oncology Hematology P A
Minneapolis, Minnesota 55404

Research Medical Center
Kansas City, Missouri 64132

Hunterdon Hematology Oncology
Flemington, New Jersey 08822

Hematology Oncology Associates of Rockland
Nyack, New York 10960

Oncology Hematology Care
Cincinnati, Ohio 45242

Willamette Valley Cancer Institute and Research Center
Eugene, Oregon 97401

OHSU Knight Cancer Institute
Portland, Oregon 97239

Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas 76104

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030

Texas Oncology-Gulf Coast
The Woodlands, Texas 77380

Community Cancer Trials of Utah
Ogden, Utah 84405

Virginia Cancer Specialists
Manassas, Virginia 20110

Virginia Oncology Associates
Virginia Beach, Virginia 23456

VA Puget Sound Healthcare System
Seattle, Washington 98108

Northwest Cancer Specialists PC
Vancouver, Washington 98684

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com