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NCT05963074Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
333 (actual)
First submitted
19 Jul 2023
Start date
30 May 2024
Primary completion date
15 Dec 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05963074
EU CT number
2023-504044-34-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 333
  • From 30 May 2024 to the primary completion date, 15 Dec 2027
  • 74 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Stroke or intracranial hemorrhage within 6 months prior to enrollment

Other illness

  • Known bleeding disorders (example, von Willebrand's disease or hemophilia)
  • 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

Lab values

  • 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

Other

  • Known or suspected Richter's transformation or central nervous system (CNS) involvement

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (74)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
QEII Health Sciences Centre
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HalifaxCanadaUnknown status
Niagara Health System
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St. CatharinesCanadaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaRecruiting
University Hospital Olomouc
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OlomoucCzechiaRecruiting
Fakultni Nemocnice Ostrava
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PorubaCzechiaRecruiting
Fakultní Nemocnice Královské Vinohrady
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Prague 10CzechiaRecruiting
Institute Of Hematology And Blood Transfusion
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Prague 2CzechiaRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Hotel Dieu
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NantesFranceRecruiting
University Hospitals Pitie Salpetriere - Charles Foix
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ParisFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryRecruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryRecruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
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NyíregyházaHungaryRecruiting
University of Pecs
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PécsHungaryRecruiting
University of Szeged
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SzegedHungaryRecruiting
Istituto Tumori Bari Giovanni Paolo II
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BariItalyRecruiting
Università degli Studi di Ferrara
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FerraraItalyRecruiting
Careggi University Hospital
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FlorenceItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyRecruiting
Azienda Ospedale Universita Padova
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PadovaItalyRecruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyRecruiting
Hospital Santa Maria Della Misericordia
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PerugiaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospealiero Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
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Biala PodlaskaPolandRecruiting
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Szpitale Pomorskie Sp z o o
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GdyniaPolandRecruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandRecruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandRecruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandRecruiting
Boise VA Medical Center
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BoiseUnited StatesUnknown status
The Oncology Institute Clinical Research
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CerritosUnited StatesUnknown status
Oncology Hematology Care
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CincinnatiUnited StatesUnknown status
Renovatio Clinical
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El PasoUnited StatesUnknown status
Willamette Valley Cancer Institute and Research Center
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EugeneUnited StatesUnknown status
Hunterdon Hematology Oncology
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FlemingtonUnited StatesUnknown status
Summit Medical Group
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Florham ParkUnited StatesUnknown status
Texas Oncology - Fort Worth Cancer Center
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Fort WorthUnited StatesUnknown status
Southeastern Medical Oncology Center
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GoldsboroUnited StatesUnknown status
Grand Valley Oncology
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Grand JunctionUnited StatesUnknown status
Hope and Healing Cancer Services
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HinsdaleUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Iowa City VA Health Care System
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Iowa CityUnited StatesUnknown status
Research Medical Center
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Kansas CityUnited StatesUnknown status
Cancer and Blood Specialty Clinic
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Los AlamitosUnited StatesUnknown status
Virginia Cancer Specialists
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ManassasUnited StatesUnknown status
Mount Sinai Medical Center Campus
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Miami BeachUnited StatesUnknown status
Minnesota Oncology Hematology, P.A.
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MinneapolisUnited StatesUnknown status
The Oncology Institute
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North Miami BeachUnited StatesUnknown status
Hematology Oncology Associates of Rockland
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NyackUnited StatesUnknown status
Community Cancer Trials of Utah
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OgdenUnited StatesUnknown status
Mid Florida Hematology Oncology
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OrangeUnited StatesUnknown status
OHSU Knight Cancer Institute
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PortlandUnited StatesUnknown status
SLO Oncology and Hematology Health Center
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San Luis ObispoUnited StatesUnknown status
Providence Medical Foundation
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Santa RosaUnited StatesUnknown status
VA Puget Sound Healthcare System
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SeattleUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Renovatio Clinical 1
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The WoodlandsUnited StatesUnknown status
Texas Oncology- Gulf Coast
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The WoodlandsUnited StatesUnknown status
Northwest Cancer Specialists, PC
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VancouverUnited StatesUnknown status
Virginia Oncology Associates
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Virginia BeachUnited StatesUnknown status
PIH Health Hospital
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WhittierUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.