RecruitingRecruiting
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT05963074 · Janssen Research & Development, LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia
About this study
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 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
Enrollment target: 320 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-05-30
Estimated completion: 2029-03-19
Last updated: 2026-06-05
Interventions
Drug: IbrutinibDrug: Venetoclax
Primary outcomes
- • Best Overall Response Rate (ORR) (Up to 5 years)
Sponsor
Janssen Research & Development, LLC · industry
With: Pharmacyclics LLC.
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (74)
The Oncology Institute Clinical ResearchRecruiting
Cerritos, California, United States
Cancer and Blood Specialty ClinicRecruiting
Los Alamitos, California, United States
SLO Oncology and Hematology Health CenterRecruiting
San Luis Obispo, California, United States
Providence Medical FoundationRecruiting
Santa Rosa, California, United States
PIH Health HospitalRecruiting
Whittier, California, United States
Grand Valley OncologyRecruiting
Grand Junction, Colorado, United States
Mount Sinai Medical Center CampusRecruiting
Miami Beach, Florida, United States
The Oncology InstituteRecruiting
North Miami Beach, Florida, United States
Mid Florida Hematology OncologyRecruiting
Orange, Florida, United States
Boise VA Medical CenterRecruiting
Boise, Idaho, United States
Hope and Healing Cancer ServicesRecruiting
Hinsdale, Illinois, United States
Springfield ClinicRecruiting
Springfield, Illinois, United States
Iowa City VA Health Care SystemRecruiting
Iowa City, Iowa, United States
Minnesota Oncology Hematology P ARecruiting
Minneapolis, Minnesota, United States
Research Medical CenterRecruiting
Kansas City, Missouri, United States
Hunterdon Hematology OncologyRecruiting
Flemington, New Jersey, United States
Summit Medical GroupCompleted
Florham Park, New Jersey, United States
Hematology Oncology Associates of RocklandRecruiting
Nyack, New York, United States
Southeastern Medical Oncology CenterCompleted
Goldsboro, North Carolina, United States
Oncology Hematology CareRecruiting
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research CenterRecruiting
Eugene, Oregon, United States
OHSU Knight Cancer InstituteRecruiting
Portland, Oregon, United States
Renovatio ClinicalCompleted
El Paso, Texas, United States
Texas Oncology-Fort Worth Cancer CenterRecruiting
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Renovatio Clinical 1Completed
The Woodlands, Texas, United States
Texas Oncology-Gulf CoastRecruiting
The Woodlands, Texas, United States
Community Cancer Trials of UtahRecruiting
Ogden, Utah, United States
Virginia Cancer SpecialistsRecruiting
Manassas, Virginia, United States
Virginia Oncology AssociatesRecruiting
Virginia Beach, Virginia, United States
VA Puget Sound Healthcare SystemRecruiting
Seattle, Washington, United States
Northwest Cancer Specialists PCRecruiting
Vancouver, Washington, United States
QEII Health Sciences CentreRecruiting
Halifax, Nova Scotia, Canada
Niagara Health SystemRecruiting
St. Catharines, Ontario, Canada
Fakultni nemocnice BrnoRecruiting
Brno-Bohunice, Czechia
Fakultni nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
Fakultni nemocnice OlomoucRecruiting
Olomouc, Czechia
Fakultni Nemocnice OstravaRecruiting
Ostrava - Poruba, Czechia
Fakultni nemocnice Kralovske VinohradyRecruiting
Prague, Czechia
Ustav Hematologie A Krevni TransfuzeRecruiting
Prague, Czechia
CHU de Clermont FerrandCompleted
Clermont-Ferrand, France
CHU NantesRecruiting
Nantes, France
Hopital Pitie SalpetriereRecruiting
Paris, France
CHU Lyon SudRecruiting
Pierre-Bénite, France
CHU de ReimsRecruiting
Reims, France
Institut de Cancerologie Strasbourg Europe ICANSCompleted
Strasbourg, France
Semmelweis EgyetemRecruiting
Budapest, Hungary
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato KorhazRecruiting
Győr, Hungary
Szabolcs Szatmar Bereg Varmegyei OktatokorhazRecruiting
Nyíregyháza, Hungary
University of SzegedRecruiting
Szeged, Hungary
U.O. Ematologia Istituto Tumori Giovanni Paolo IIRecruiting
Bari, Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant AnnaRecruiting
Ferrara, Italy
Azienda Ospedaliero Universitaria CareggiRecruiting
Florence, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
ASST Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Ospedale Maggiore della CaritaRecruiting
Novara, Italy
Universita degli Studi di Padova Azienda Ospedaliera di PaRecruiting
Padova, Italy
Ospedale Villa Sofia-CervelloRecruiting
Palermo, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della MisericordiaRecruiting
Perugia, Italy
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro CuoreRecruiting
Roma, Italy
Umberto I Policlinico di RomaRecruiting
Roma, Italy
Wojewodzki Szpital SpecjalistycznyRecruiting
Biała Podlaska, Poland
Szpital Specjalistyczny w BrzozowieRecruiting
Brzozów, Poland
Szpitale Pomorskie Sp z o oRecruiting
Gdynia, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w KielcachRecruiting
Kielce, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w KrakowieRecruiting
Krakow, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w LodziRecruiting
Lodz, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z DukliRecruiting
Lublin, Poland
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp Reina SofiaRecruiting
Córdoba, Spain
Hosp. Univ. Ramon Y CajalRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Hosp. Univ. Marques de ValdecillaRecruiting
Santander, Spain
Hosp. Clinico Univ. de SantiagoRecruiting
Santiago de Compostela, Spain