Trial Title:
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT ID:
NCT05963074
Condition:
Leukemia, Lymphocytic, Chronic, B-Cell
Small Lymphocytic Lymphoma
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Venetoclax
Ibrutinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ibrutinib
Description:
Ibrutinib capsules will be administered orally.
Arm group label:
Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
Arm group label:
Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
Arm group label:
Cohort 2a: Continuous Ibrutinib Monotherapy
Arm group label:
Cohort 2b: Continuous Ibrutinib Monotherapy
Other name:
JNJ-54179060, IMBRUVICA
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax tablets will be administered orally.
Arm group label:
Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
Arm group label:
Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
Other name:
VENCLEXTA, VENCLYXTO
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Oncology Institute Clinical Research
Address:
City:
Cerritos
Zip:
90703
Country:
United States
Status:
Recruiting
Facility:
Name:
SLO Oncology and Hematology Health Center
Address:
City:
San Luis Obispo
Zip:
93401
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Medical Foundation
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Status:
Recruiting
Facility:
Name:
PIH Health Hospital
Address:
City:
Whittier
Zip:
90602
Country:
United States
Status:
Recruiting
Facility:
Name:
Grand Valley Oncology
Address:
City:
Grand Junction
Zip:
81505
Country:
United States
Status:
Recruiting
Facility:
Name:
Mount Sinai Medical Center Campus
Address:
City:
Miami Beach
Zip:
33140-2948
Country:
United States
Status:
Recruiting
Facility:
Name:
The Oncology Institute
Address:
City:
North Miami Beach
Zip:
33169
Country:
United States
Status:
Recruiting
Facility:
Name:
Boise VA Medical Center
Address:
City:
Boise
Zip:
83702
Country:
United States
Status:
Recruiting
Facility:
Name:
Hope and Healing Cancer Services
Address:
City:
Hinsdale
Zip:
60521
Country:
United States
Status:
Recruiting
Facility:
Name:
Springfield Clinic
Address:
City:
Springfield
Zip:
62702
Country:
United States
Status:
Recruiting
Facility:
Name:
Iowa City VA Health Care System
Address:
City:
Iowa City
Zip:
52246
Country:
United States
Status:
Recruiting
Facility:
Name:
Minnesota Oncology Hematology P A
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Medical Center
Address:
City:
Kansas City
Zip:
64132
Country:
United States
Status:
Recruiting
Facility:
Name:
Hunterdon Hematology Oncology
Address:
City:
Flemington
Zip:
08822
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Medical Group
Address:
City:
Florham Park
Zip:
07932
Country:
United States
Status:
Recruiting
Facility:
Name:
Hematology Oncology Associates of Rockland
Address:
City:
Nyack
Zip:
10960
Country:
United States
Status:
Recruiting
Facility:
Name:
Southeastern Medical Oncology Center
Address:
City:
Goldsboro
Zip:
27534
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Care
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Facility:
Name:
Willamette Valley Cancer Institute and Research Center
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology-Fort Worth Cancer Center
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology-Gulf Coast
Address:
City:
The Woodlands
Zip:
77380
Country:
United States
Status:
Recruiting
Facility:
Name:
Community Cancer Trials of Utah
Address:
City:
Ogden
Zip:
84405
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Gainesville
Zip:
20155
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Oncology Associates
Address:
City:
Virginia Beach
Zip:
23456
Country:
United States
Status:
Recruiting
Facility:
Name:
VA Puget Sound Healthcare System
Address:
City:
Seattle
Zip:
98108
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Cancer Specialists PC
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Recruiting
Facility:
Name:
QEII Health Sciences Centre
Address:
City:
Halifax
Zip:
B3H 1V7
Country:
Canada
Status:
Recruiting
Facility:
Name:
Niagara Health System
Address:
City:
St. Catharines
Zip:
L2S 0A9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Brno
Address:
City:
Brno - Bohunice
Zip:
625 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Hradec Kralove
Address:
City:
Hradec Kralove
Zip:
500 05
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Olomouc
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni Nemocnice Ostrava
Address:
City:
Ostrava - Poruba
Zip:
708 52
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni nemocnice Kralovske Vinohrady
Address:
City:
Praha 10
Zip:
100 34
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Ustav Hematologie A Krevni Transfuze
Address:
City:
Praha 2
Zip:
128 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
CHU de Clermont Ferrand
Address:
City:
Clermont-Ferrand
Zip:
63100
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Nantes
Address:
City:
Nantes Cedex 1
Zip:
44000
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Pitie Salpetriere
Address:
City:
Paris cedex 13
Zip:
75651
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Lyon Sud
Address:
City:
Pierre-Benite
Zip:
69495
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Reims
Address:
City:
Reims
Zip:
51100
Country:
France
Status:
Recruiting
Facility:
Name:
Institut de Cancerologie Strasbourg Europe ICANS
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Status:
Recruiting
Facility:
Name:
Semmelweis Egyetem
Address:
City:
Budapest
Zip:
1088
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Address:
City:
Gyor
Zip:
9024
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Address:
City:
Nyiregyhaza
Zip:
4400
Country:
Hungary
Status:
Recruiting
Facility:
Name:
University of Szeged
Address:
City:
Szeged
Zip:
6725
Country:
Hungary
Status:
Recruiting
Facility:
Name:
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
Address:
City:
Ferrara
Zip:
44124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Careggi
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Maggiore della Carita
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Address:
City:
Padova
Zip:
35129
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Villa Sofia-Cervello
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Address:
City:
Roma
Zip:
00136
Country:
Italy
Status:
Recruiting
Facility:
Name:
Umberto I Policlinico di Roma
Address:
City:
Roma
Zip:
00161
Country:
Italy
Status:
Recruiting
Facility:
Name:
Wojewodzki Szpital Specjalistyczny
Address:
City:
Biala Podlaska
Zip:
21 500
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Address:
City:
Brzozow
Zip:
36-200
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpitale Pomorskie Sp z o o
Address:
City:
Gdynia
Zip:
81-519
Country:
Poland
Status:
Recruiting
Facility:
Name:
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Address:
City:
Kielce
Zip:
25-734
Country:
Poland
Status:
Recruiting
Facility:
Name:
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Address:
City:
Krakow
Zip:
30-688
Country:
Poland
Status:
Recruiting
Facility:
Name:
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Address:
City:
Lodz
Zip:
93-513
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Address:
City:
Lublin
Zip:
20-090
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hosp Univ Vall D Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Reina Sofia
Address:
City:
Cordoba
Zip:
14004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Ramon Y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Univ. Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp. Clinico Univ. de Santiago
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Start date:
January 31, 2024
Completion date:
March 19, 2029
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Collaborator:
Agency:
Pharmacyclics LLC.
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963074
