Actively Recruiting
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
320
Participants Needed
73
Research Sites
250 weeks
Total Duration
On this page
Sponsors
J
Janssen Research & Development, LLC
Lead Sponsor
P
Pharmacyclics LLC.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma by iwCLL 2018 criteria
- ECOG performance status 0-1 for ibrutinib + venetoclax groups; 0-2 for ibrutinib alone groups
- At least one lymph node 1.5 cm or larger by CT scan
- Use of additional contraceptive method if using oral contraceptives
- Agreement to avoid pregnancy, breastfeeding, or planning pregnancy during study and for 1 month after last dose or per local guidelines
You will not qualify if you...
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura within 4 weeks before treatment or needing prednisone >20 mg daily
- Known bleeding disorders like von Willebrand's disease or hemophilia
- Stroke or brain hemorrhage within 6 months before enrollment
- Known or suspected Richter's transformation or central nervous system involvement
- Active serious cardiovascular disease such as uncontrolled arrhythmia or Class II-IV congestive heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 73 locations
1
The Oncology Institute Clinical Research
Cerritos, California, United States, 90703
Actively Recruiting
2
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
Actively Recruiting
3
SLO Oncology and Hematology Health Center
San Luis Obispo, California, United States, 93401
Actively Recruiting
4
Providence Medical Foundation
Santa Rosa, California, United States, 95403
Actively Recruiting
5
PIH Health Hospital
Whittier, California, United States, 90602
Actively Recruiting
6
Grand Valley Oncology
Grand Junction, Colorado, United States, 81505
Actively Recruiting
7
Mount Sinai Medical Center Campus
Miami Beach, Florida, United States, 33140-2948
Actively Recruiting
8
The Oncology Institute
North Miami Beach, Florida, United States, 33169
Actively Recruiting
9
Mid Florida Hematology Oncology
Orange, Florida, United States, 32763
Actively Recruiting
10
Boise VA Medical Center
Boise, Idaho, United States, 83702
Actively Recruiting
11
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Actively Recruiting
12
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
13
Iowa City VA Health Care System
Iowa City, Iowa, United States, 52246
Actively Recruiting
14
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
15
Research Medical Center
Kansas City, Missouri, United States, 64132
Actively Recruiting
16
Hunterdon Hematology Oncology
Flemington, New Jersey, United States, 08822
Actively Recruiting
17
Summit Medical Group
Florham Park, New Jersey, United States, 07932
Completed
18
Hematology Oncology Associates of Rockland
Nyack, New York, United States, 10960
Actively Recruiting
19
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
Completed
20
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
Actively Recruiting
21
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
Actively Recruiting
22
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
23
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
24
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
25
Renovatio Clinical 1
The Woodlands, Texas, United States, 77380
Completed
26
Texas Oncology-Gulf Coast
The Woodlands, Texas, United States, 77380
Actively Recruiting
27
Community Cancer Trials of Utah
Ogden, Utah, United States, 84405
Actively Recruiting
28
Virginia Cancer Specialists
Manassas, Virginia, United States, 20110
Actively Recruiting
29
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
Actively Recruiting
30
VA Puget Sound Healthcare System
Seattle, Washington, United States, 98108
Actively Recruiting
31
Northwest Cancer Specialists PC
Vancouver, Washington, United States, 98684
Actively Recruiting
32
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Actively Recruiting
33
Niagara Health System
St. Catharines, Ontario, Canada, L2S 0A9
Actively Recruiting
34
Fakultni nemocnice Brno
Brno-Bohunice, Czechia, 625 00
Actively Recruiting
35
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
36
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
Actively Recruiting
37
Fakultni Nemocnice Ostrava
Ostrava - Poruba, Czechia, 708 52
Actively Recruiting
38
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
39
Ustav Hematologie A Krevni Transfuze
Prague, Czechia, 128 00
Actively Recruiting
40
CHU de Clermont Ferrand
Clermont-Ferrand, France, 63100
Completed
41
CHU Nantes
Nantes, France, 44000
Actively Recruiting
42
Hopital Pitie Salpetriere
Paris, France, 75651
Actively Recruiting
43
CHU Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
44
CHU de Reims
Reims, France, 51100
Actively Recruiting
45
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, France, 67200
Completed
46
Semmelweis Egyetem
Budapest, Hungary, 1088
Actively Recruiting
47
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary, 9024
Actively Recruiting
48
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza, Hungary, 4400
Actively Recruiting
49
University of Szeged
Szeged, Hungary, 6725
Actively Recruiting
50
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Actively Recruiting
51
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
Ferrara, Italy, 44124
Actively Recruiting
52
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
53
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
54
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
55
Ospedale Maggiore della Carita
Novara, Italy, 28100
Actively Recruiting
56
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padova, Italy, 35129
Actively Recruiting
57
Ospedale Villa Sofia-Cervello
Palermo, Italy, 90146
Actively Recruiting
58
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, Italy, 06132
Actively Recruiting
59
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, Italy, 00136
Actively Recruiting
60
Umberto I Policlinico di Roma
Roma, Italy, 00161
Actively Recruiting
61
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, Poland, 21 500
Actively Recruiting
62
Szpital Specjalistyczny w Brzozowie
Brzozów, Poland, 36 200
Actively Recruiting
63
Szpitale Pomorskie Sp z o o
Gdynia, Poland, 81-519
Actively Recruiting
64
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, Poland, 25 734
Actively Recruiting
65
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30 688
Actively Recruiting
66
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, Poland, 93 513
Actively Recruiting
67
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, Poland, 20 090
Actively Recruiting
68
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
69
Hosp Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
70
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
71
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
72
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
73
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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