RecruitingInterventionalPhase 2

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

NCT ID: NCT05963074Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

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).

Arms & interventions

DrugIbrutinib
Ibrutinib capsules will be administered orally.
DrugVenetoclax
Venetoclax tablets will be administered orally.

Outcome measures

Primary

Best Overall Response Rate (ORR)
Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator.
Time frame: Up to 5 years

Secondary

Complete Response (CR) Rate
Time frame: Up to 5 years
Duration of Response (DOR)
Time frame: Up to 5 years
Progression Free Survival (PFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate
Time frame: Up to 5 years
Number of Participants with Adverse Events (AEs)
Time frame: Up to 5 years
Number of Participants with AEs by Severity
Time frame: Up to 5 years
Percentage of Participants with Rate of Discontinuation due to AEs
Time frame: Up to 5 years
Percentage of Participants with Dose Reduction due AEs
Time frame: Up to 5 years
Adherence Rates
Time frame: Up to 5 years
Duration of Treatment
Time frame: Up to 5 years
Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)
Time frame: Up to 5 years
Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
Time frame: Up to 5 years
Time to Worsening as Measured by EORTC QLQ-CLL17
Time frame: Up to 5 years
Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (32)

The Oncology Institute Clinical Research

Cerritos, California, 90703

Recruiting

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720

Recruiting

SLO Oncology and Hematology Health Center

San Luis Obispo, California, 93401

Recruiting

Providence Medical Foundation

Santa Rosa, California, 95403

Recruiting

PIH Health Hospital

Whittier, California, 90602

Recruiting

Grand Valley Oncology

Grand Junction, Colorado, 81505

Recruiting

Mount Sinai Medical Center Campus

Miami Beach, Florida, 33140-2948

Recruiting

The Oncology Institute

North Miami Beach, Florida, 33169

Recruiting

Mid Florida Hematology Oncology

Orange, Florida, 32763

Recruiting

Boise VA Medical Center

Boise, Idaho, 83702

Recruiting

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521

Recruiting

Springfield Clinic

Springfield, Illinois, 62702

Recruiting

Iowa City VA Health Care System

Iowa City, Iowa, 52246

Recruiting

Minnesota Oncology Hematology P A

Minneapolis, Minnesota, 55404

Recruiting

Research Medical Center

Kansas City, Missouri, 64132

Recruiting

Hunterdon Hematology Oncology

Flemington, New Jersey, 08822

Recruiting

Summit Medical Group

Florham Park, New Jersey, 07932

Completed

Hematology Oncology Associates of Rockland

Nyack, New York, 10960

Recruiting

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534

Completed

Oncology Hematology Care

Cincinnati, Ohio, 45242

Recruiting

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401

Recruiting

OHSU Knight Cancer Institute

Portland, Oregon, 97239

Recruiting

Renovatio Clinical

El Paso, Texas, 79915

Completed

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, 76104

Recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Renovatio Clinical 1

The Woodlands, Texas, 77380

Completed

Texas Oncology-Gulf Coast

The Woodlands, Texas, 77380

Recruiting

Community Cancer Trials of Utah

Ogden, Utah, 84405

Recruiting

Virginia Cancer Specialists

Manassas, Virginia, 20110

Recruiting

Virginia Oncology Associates

Virginia Beach, Virginia, 23456

Recruiting

VA Puget Sound Healthcare System

Seattle, Washington, 98108

Recruiting

Northwest Cancer Specialists PC

Vancouver, Washington, 98684

Recruiting