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
- Diseases
- Chronic lymphocytic leukaemia
- 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
Sites (74)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| QEII Health Sciences Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Niagara Health System Coordinator of this site? Confirm its status | St. Catharines | Canada | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Fakultni Nemocnice Ostrava Coordinator of this site? Confirm its status | Poruba | Czechia | Recruiting |
| Fakultní Nemocnice Královské Vinohrady Coordinator of this site? Confirm its status | Prague 10 | Czechia | Recruiting |
| Institute Of Hematology And Blood Transfusion Coordinator of this site? Confirm its status | Prague 2 | Czechia | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| University Hospitals Pitie Salpetriere - Charles Foix Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Recruiting |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| Istituto Tumori Bari Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Università degli Studi di Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospealiero Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Coordinator of this site? Confirm its status | Biala Podlaska | Poland | Recruiting |
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Coordinator of this site? Confirm its status | Brzozów | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Boise VA Medical Center Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| The Oncology Institute Clinical Research Coordinator of this site? Confirm its status | Cerritos | United States | Unknown status |
| Oncology Hematology Care Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Renovatio Clinical Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Willamette Valley Cancer Institute and Research Center Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Hunterdon Hematology Oncology Coordinator of this site? Confirm its status | Flemington | United States | Unknown status |
| Summit Medical Group Coordinator of this site? Confirm its status | Florham Park | United States | Unknown status |
| Texas Oncology - Fort Worth Cancer Center Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Southeastern Medical Oncology Center Coordinator of this site? Confirm its status | Goldsboro | United States | Unknown status |
| Grand Valley Oncology Coordinator of this site? Confirm its status | Grand Junction | United States | Unknown status |
| Hope and Healing Cancer Services Coordinator of this site? Confirm its status | Hinsdale | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Iowa City VA Health Care System Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Research Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Cancer and Blood Specialty Clinic Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Mount Sinai Medical Center Campus Coordinator of this site? Confirm its status | Miami Beach | United States | Unknown status |
| Minnesota Oncology Hematology, P.A. Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| The Oncology Institute Coordinator of this site? Confirm its status | North Miami Beach | United States | Unknown status |
| Hematology Oncology Associates of Rockland Coordinator of this site? Confirm its status | Nyack | United States | Unknown status |
| Community Cancer Trials of Utah Coordinator of this site? Confirm its status | Ogden | United States | Unknown status |
| Mid Florida Hematology Oncology Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| OHSU Knight Cancer Institute Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| SLO Oncology and Hematology Health Center Coordinator of this site? Confirm its status | San Luis Obispo | United States | Unknown status |
| Providence Medical Foundation Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| VA Puget Sound Healthcare System Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Renovatio Clinical 1 Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Texas Oncology- Gulf Coast Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Northwest Cancer Specialists, PC Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
| PIH Health Hospital Coordinator of this site? Confirm its status | Whittier | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.