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

Last updated: May 22, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphocytic Leukemia, Chronic

Chronic Lymphocytic Leukemia

Leukemia

Treatment

Ibrutinib

Venetoclax

Clinical Study ID

NCT05963074
54179060CLL2032
54179060CLL2032
2023-504044-34-00
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) asper International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnosticcriteria

  • For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG)performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performancestatus of 0-2

  • Measurable nodal disease by computed tomography (CT), defined as at least 1 lymphnode 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 becomepregnant while enrolled in this study or until 1 month after last dose or per locallabel if more conservative (for example, 3 months in European Union or Canada and 1month in United States)

Exclusion

Exclusion Criteria:

  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura,such as those participants with a declining hemoglobin level or platelet countsecondary to autoimmune destruction within the 4 weeks prior to first dose of studytreatment, or the need for prednisone greater than (>) 20 milligrams (mg) daily (orcorticosteroid 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 asuncontrolled arrhythmia or Class II, III, or IV congestive heart failure as definedby the New York Heart Association Functional Classification

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Ibrutinib
Phase: 2
Study Start date:
May 30, 2024
Estimated Completion Date:
March 19, 2029

Connect with a study center

  • QEII Health Sciences Centre

    Halifax, Nova Scotia B3H 1V7
    Canada

    Active - Recruiting

  • Niagara Health System

    St. Catharines, Ontario L2S 0A9
    Canada

    Active - Recruiting

  • Fakultni nemocnice Brno

    Brno - Bohunice, 625 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Fakultní nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Active - Recruiting

  • Ustav Hematologie A Krevni Transfuze

    Praha 2, 128 00
    Czechia

    Active - Recruiting

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63100
    France

    Active - Recruiting

  • CHU Nantes

    Nantes Cedex 1, 44000
    France

    Active - Recruiting

  • Hopital Pitie Salpetriere

    Paris cedex 13, 75651
    France

    Active - Recruiting

  • CHU Lyon Sud

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • CHU de Reims

    Reims, 51100
    France

    Active - Recruiting

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67200
    France

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Active - Recruiting

  • Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Gyor, 9024
    Hungary

    Active - Recruiting

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyiregyhaza, 4400
    Hungary

    Active - Recruiting

  • University of Szeged

    Szeged, 6725
    Hungary

    Active - Recruiting

  • U.O. Ematologia Istituto Tumori Giovanni Paolo II

    Bari, 70124
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna

    Ferrara, 44124
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Firenze, 50134
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • Ospedale Maggiore della Carita

    Novara, 28100
    Italy

    Active - Recruiting

  • Universita degli Studi di Padova Azienda Ospedaliera di Pa

    Padova, 35129
    Italy

    Active - Recruiting

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

    Perugia, 06132
    Italy

    Active - Recruiting

  • Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore

    Roma, 00136
    Italy

    Active - Recruiting

  • Umberto I Policlinico di Roma

    Roma, 00161
    Italy

    Active - Recruiting

  • Wojewodzki Szpital Specjalistyczny

    Biala Podlaska, 21 500
    Poland

    Active - Recruiting

  • Szpital Specjalistyczny w Brzozowie

    Brzozow, 36 200
    Poland

    Active - Recruiting

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozow, 36-200
    Poland

    Active - Recruiting

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81-519
    Poland

    Active - Recruiting

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734
    Poland

    Active - Recruiting

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30 688
    Poland

    Active - Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 513
    Poland

    Active - Recruiting

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090
    Poland

    Active - Recruiting

  • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

    Lublin, 20-090
    Poland

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp Reina Sofia

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • The Oncology Institute Clinical Research

    Cerritos, California 90703
    United States

    Active - Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • SLO Oncology and Hematology Health Center

    San Luis Obispo, California 93401
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • PIH Health Hospital

    Whittier, California 90602
    United States

    Active - Recruiting

  • Grand Valley Oncology

    Grand Junction, Colorado 81505
    United States

    Active - Recruiting

  • Mount Sinai Medical Center Campus

    Miami Beach, Florida 33140-2948
    United States

    Active - Recruiting

  • The Oncology Institute

    North Miami Beach, Florida 33169
    United States

    Active - Recruiting

  • Mid Florida Hematology Oncology

    Orange, Florida 32763
    United States

    Active - Recruiting

  • Boise VA Medical Center

    Boise, Idaho 83702
    United States

    Active - Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Springfield Clinic

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Iowa City VA Health Care System

    Iowa City, Iowa 52246
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology P A

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Research Medical Center

    Kansas City, Missouri 64132
    United States

    Active - Recruiting

  • Hunterdon Hematology Oncology

    Flemington, New Jersey 08822
    United States

    Active - Recruiting

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Completed

  • Hematology Oncology Associates of Rockland

    Nyack, New York 10960
    United States

    Active - Recruiting

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina 27534
    United States

    Completed

  • Oncology Hematology Care

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Renovatio Clinical

    El Paso, Texas 79915
    United States

    Active - Recruiting

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Renovatio Clinical

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • Texas Oncology-Gulf Coast

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • Community Cancer Trials of Utah

    Ogden, Utah 84405
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Gainesville, Virginia 20155
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Virginia Beach, Virginia 23456
    United States

    Active - Recruiting

  • VA Puget Sound Healthcare System

    Seattle, Washington 98108
    United States

    Active - Recruiting

  • Northwest Cancer Specialists PC

    Vancouver, Washington 98684
    United States

    Active - Recruiting

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