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A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor: Janssen Research & Development, LLC
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).
Official title: Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2024-05-30
Completion Date
2029-03-19
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Ibrutinib
Ibrutinib capsules will be administered orally.
Venetoclax
Venetoclax tablets will be administered orally.
Locations (73)
The Oncology Institute Clinical Research
Cerritos, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
SLO Oncology and Hematology Health Center
San Luis Obispo, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
PIH Health Hospital
Whittier, California, United States
Grand Valley Oncology
Grand Junction, Colorado, United States
Mount Sinai Medical Center Campus
Miami Beach, Florida, United States
The Oncology Institute
North Miami Beach, Florida, United States
Mid Florida Hematology Oncology
Orange, Florida, United States
Boise VA Medical Center
Boise, Idaho, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Iowa City VA Health Care System
Iowa City, Iowa, United States
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, United States
Research Medical Center
Kansas City, Missouri, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
Texas Oncology-Gulf Coast
The Woodlands, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Virginia Cancer Specialists
Manassas, Virginia, United States
Virginia Oncology Associates
Virginia Beach, Virginia, United States
VA Puget Sound Healthcare System
Seattle, Washington, United States
Northwest Cancer Specialists PC
Vancouver, Washington, United States
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Niagara Health System
St. Catharines, Ontario, Canada
Fakultni nemocnice Brno
Brno-Bohunice, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Ustav Hematologie A Krevni Transfuze
Prague, Czechia
CHU de Clermont Ferrand
Clermont-Ferrand, France
CHU Nantes
Nantes, France
Hopital Pitie Salpetriere
Paris, France
CHU Lyon Sud
Pierre-Bénite, France
CHU de Reims
Reims, France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, France
Semmelweis Egyetem
Budapest, Hungary
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza, Hungary
University of Szeged
Szeged, Hungary
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
Ferrara, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Ospedale San Raffaele
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Ospedale Maggiore della Carita
Novara, Italy
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padova, Italy
Ospedale Villa Sofia-Cervello
Palermo, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, Italy
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, Italy
Umberto I Policlinico di Roma
Roma, Italy
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, Poland
Szpital Specjalistyczny w Brzozowie
Brzozów, Poland
Szpitale Pomorskie Sp z o o
Gdynia, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, Poland
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Reina Sofia
Córdoba, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp. Univ. Marques de Valdecilla
Santander, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain