Clinical trial NCT05963074: A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
Official title: Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Small Lymphocytic Lymphoma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pharmacyclics LLC.
First posted: 2023-07-27
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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

Primary outcomes:
measure: Best Overall Response Rate (ORR)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Complete Response (CR) Rate
timeFrame: Up to 5 years
measure: Duration of Response (DOR)
timeFrame: Up to 5 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 5 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate
timeFrame: Up to 5 years
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 5 years
measure: Number of Participants with AEs by Severity
timeFrame: Up to 5 years
measure: Percentage of Participants with Rate of Discontinuation due to AEs
timeFrame: Up to 5 years
measure: Percentage of Participants with Dose Reduction due AEs
timeFrame: Up to 5 years
measure: Adherence Rates
timeFrame: Up to 5 years
measure: Duration of Treatment
timeFrame: Up to 5 years
measure: Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)
timeFrame: Up to 5 years
measure: Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
timeFrame: Up to 5 years
measure: Time to Worsening as Measured by EORTC QLQ-CLL17
timeFrame: Up to 5 years
measure: Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: The Oncology Institute Clinical Research
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: San Luis Obispo
country: United States
facility: SLO Oncology and Hematology Health Center
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: Whittier
country: United States
facility: PIH Health Hospital
state: California
city: Grand Junction
country: United States
facility: Grand Valley Oncology
state: Colorado
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center Campus
state: Florida
city: North Miami Beach
country: United States
facility: The Oncology Institute
state: Florida
city: Orange
country: United States
facility: Mid Florida Hematology Oncology
state: Florida
city: Boise
country: United States
facility: Boise VA Medical Center
state: Idaho
city: Hinsdale
country: United States
facility: Hope and Healing Cancer Services
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Iowa City
country: United States
facility: Iowa City VA Health Care System
state: Iowa
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology P A
state: Minnesota
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Flemington
country: United States
facility: Hunterdon Hematology Oncology
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: El Paso
country: United States
facility: Renovatio Clinical
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Fort Worth Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology-Gulf Coast
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Manassas
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Healthcare System
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists PC
state: Washington
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: St. Catharines
country: Canada
facility: Niagara Health System
state: Ontario
city: Brno - Bohunice
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava - Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Ustav Hematologie A Krevni Transfuze
city: Clermont-Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Nantes Cedex 1
country: France
facility: CHU Nantes
city: Paris cedex 13
country: France
facility: Hopital Pitie Salpetriere
city: Pierre-Benite
country: France
facility: CHU Lyon Sud
city: Reims
country: France
facility: CHU de Reims
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe ICANS
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Gyor
country: Hungary
facility: Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
city: Szeged
country: Hungary
facility: University of Szeged
city: Bari
country: Italy
facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Novara
country: Italy
facility: Ospedale Maggiore della Carita
city: Padova
country: Italy
facility: Universita degli Studi di Padova Azienda Ospedaliera di Pa
city: Palermo
country: Italy
facility: Ospedale Villa Sofia-Cervello
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
city: Roma
country: Italy
facility: Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
city: Roma
country: Italy
facility: Umberto I Policlinico di Roma
city: Biala Podlaska
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp z o o
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
city: Krakow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: