Actively Recruiting
Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
320
Participants Needed
74
Research Sites
65 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
Researchers are evaluating the effectiveness and safety of different ibrutinib treatment plans, alone or combined with venetoclax, for people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. This Phase 2 study compares regimens where ibrutinib dosing is either proactively reduced or adjusted in response to side effects. The goal is to find the best way to customize treatment while monitoring responses and adverse events. Participants receive ibrutinib capsules daily for a lead-in period of three 28-day cycles. Starting with cycle 4, some groups add venetoclax tablets with a gradual dose increase over five weeks, continuing both drugs daily for 12 cycles, while others continue ibrutinib alone at either the full or a reduced dose until disease progression or unacceptable side effects. Four different treatment arms explore these variations, including fixed duration and continuous therapy options. During the study, participants undergo regular evaluations to monitor cancer response, side effects, and quality of life for up to five years. Assessments include imaging scans to measure lymph nodes, blood tests, and questionnaires about symptoms and fatigue. Researchers track outcomes like overall response rate, survival, adverse events, treatment adherence, and changes in health status over time to understand the impact of each treatment plan.
CONDITIONS
Brief 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 per iwCLL 2018 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for ibrutinib plus venetoclax groups
- ECOG performance status 0-2 for ibrutinib monotherapy groups
- Measurable lymph node disease by CT scan with at least one lymph node 1.5 cm or larger
- Use of oral contraceptives plus an additional contraceptive method if applicable
- Agreement not to be pregnant, breastfeeding, or planning pregnancy during study and for 1 month after last dose
You will not qualify if you...
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura with recent declines in blood counts or high-dose prednisone use
- Known bleeding disorders such as von Willebrand's disease or hemophilia
- Stroke or brain bleeding within 6 months before enrollment
- Known or suspected Richter's transformation or central nervous system involvement
- Active, serious heart conditions like uncontrolled arrhythmia or advanced congestive heart failure (NYHA Class II-IV)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive oral ibrutinib, with some cohorts also receiving venetoclax following a dose ramp-up. Treatment duration varies by cohort and continues until disease progression or unacceptable toxicity.
Monthly visits for treatment cycles of 28 days
Trial Site Locations
Total: 74 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
Renovatio Clinical
El Paso, Texas, United States, 79915
Completed
24
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
25
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
26
Renovatio Clinical 1
The Woodlands, Texas, United States, 77380
Completed
27
Texas Oncology-Gulf Coast
The Woodlands, Texas, United States, 77380
Actively Recruiting
28
Community Cancer Trials of Utah
Ogden, Utah, United States, 84405
Actively Recruiting
29
Virginia Cancer Specialists
Manassas, Virginia, United States, 20110
Actively Recruiting
30
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
Actively Recruiting
31
VA Puget Sound Healthcare System
Seattle, Washington, United States, 98108
Actively Recruiting
32
Northwest Cancer Specialists PC
Vancouver, Washington, United States, 98684
Actively Recruiting
33
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Actively Recruiting
34
Niagara Health System
St. Catharines, Ontario, Canada, L2S 0A9
Actively Recruiting
35
Fakultni nemocnice Brno
Brno-Bohunice, Czechia, 625 00
Actively Recruiting
36
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
37
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
Actively Recruiting
38
Fakultni Nemocnice Ostrava
Ostrava - Poruba, Czechia, 708 52
Actively Recruiting
39
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
40
Ustav Hematologie A Krevni Transfuze
Prague, Czechia, 128 00
Actively Recruiting
41
CHU de Clermont Ferrand
Clermont-Ferrand, France, 63100
Completed
42
CHU Nantes
Nantes, France, 44000
Actively Recruiting
43
Hopital Pitie Salpetriere
Paris, France, 75651
Actively Recruiting
44
CHU Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
45
CHU de Reims
Reims, France, 51100
Actively Recruiting
46
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, France, 67200
Completed
47
Semmelweis Egyetem
Budapest, Hungary, 1088
Actively Recruiting
48
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary, 9024
Actively Recruiting
49
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza, Hungary, 4400
Actively Recruiting
50
University of Szeged
Szeged, Hungary, 6725
Actively Recruiting
51
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Actively Recruiting
52
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
Ferrara, Italy, 44124
Actively Recruiting
53
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
54
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
55
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
56
Ospedale Maggiore della Carita
Novara, Italy, 28100
Actively Recruiting
57
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padova, Italy, 35129
Actively Recruiting
58
Ospedale Villa Sofia-Cervello
Palermo, Italy, 90146
Actively Recruiting
59
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, Italy, 06132
Actively Recruiting
60
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, Italy, 00136
Actively Recruiting
61
Umberto I Policlinico di Roma
Roma, Italy, 00161
Actively Recruiting
62
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, Poland, 21 500
Actively Recruiting
63
Szpital Specjalistyczny w Brzozowie
Brzozów, Poland, 36 200
Actively Recruiting
64
Szpitale Pomorskie Sp z o o
Gdynia, Poland, 81-519
Actively Recruiting
65
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, Poland, 25 734
Actively Recruiting
66
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30 688
Actively Recruiting
67
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, Poland, 93 513
Actively Recruiting
68
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, Poland, 20 090
Actively Recruiting
69
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
70
Hosp Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
71
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
72
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
73
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
74
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
Research Team
S
Study 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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