A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT ID: NCT05963074
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
320 participants
INTERVENTIONAL
2024-05-30
2029-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15.
Ibrutinib
Ibrutinib capsules will be administered orally.
Venetoclax
Venetoclax tablets will be administered orally.
Cohort 2a: Continuous Ibrutinib Monotherapy
Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.
Ibrutinib
Ibrutinib capsules will be administered orally.
Cohort 2b: Continuous Ibrutinib Monotherapy
Participants will receive ibrutinib 420 mg QD for 1 cycle (1 cycle = 28 days) followed by Ibrutinib 280 mg QD (or last tolerated dose) and continue until disease progression or unacceptable toxicity.
Ibrutinib
Ibrutinib capsules will be administered orally.
Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15.
Ibrutinib
Ibrutinib capsules will be administered orally.
Venetoclax
Venetoclax tablets will be administered orally.
Interventions
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Ibrutinib
Ibrutinib capsules will be administered orally.
Venetoclax
Venetoclax tablets will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Renovatio Clinical
El Paso, Texas, 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
Padua, , 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
Countries
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Central Contacts
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Other Identifiers
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54179060CLL2032
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504044-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
54179060CLL2032
Identifier Type: -
Identifier Source: org_study_id