A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia
TAILOR
Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia
2 other identifiers
interventional
320
8 countries
73
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
Longer than P75 for phase_2
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 19, 2029
April 13, 2026
April 1, 2026
3.5 years
July 19, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Best Overall Response Rate (ORR)
Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator.
Up to 5 years
Secondary Outcomes (15)
Complete Response (CR) Rate
Up to 5 years
Duration of Response (DOR)
Up to 5 years
Progression Free Survival (PFS)
Up to 5 years
Overall Survival (OS)
Up to 5 years
Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate
Up to 5 years
- +10 more secondary outcomes
Study Arms (4)
Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
EXPERIMENTALParticipants 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.
Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
EXPERIMENTALParticipants 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.
Cohort 2a: Continuous Ibrutinib Monotherapy
EXPERIMENTALParticipants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.
Cohort 2b: Continuous Ibrutinib Monotherapy
EXPERIMENTALParticipants 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.
Interventions
Ibrutinib capsules will be administered orally.
Venetoclax tablets will be administered orally.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Pharmacyclics LLC.collaborator
Study Sites (73)
The Oncology Institute Clinical Research
Cerritos, California, 90703, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720, United States
SLO Oncology and Hematology Health Center
San Luis Obispo, California, 93401, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
PIH Health Hospital
Whittier, California, 90602, United States
Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
Mount Sinai Medical Center Campus
Miami Beach, Florida, 33140-2948, United States
The Oncology Institute
North Miami Beach, Florida, 33169, United States
Mid Florida Hematology Oncology
Orange, Florida, 32763, United States
Boise VA Medical Center
Boise, Idaho, 83702, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Iowa City VA Health Care System
Iowa City, Iowa, 52246, United States
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, 55404, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, 76104, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Renovatio Clinical 1
The Woodlands, Texas, 77380, United States
Texas Oncology-Gulf Coast
The Woodlands, Texas, 77380, United States
Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
Virginia Cancer Specialists
Manassas, Virginia, 20110, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108, United States
Northwest Cancer Specialists PC
Vancouver, Washington, 98684, United States
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Niagara Health System
St. Catharines, Ontario, L2S 0A9, Canada
Fakultni nemocnice Brno
Brno-Bohunice, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Ustav Hematologie A Krevni Transfuze
Prague, 128 00, Czechia
CHU de Clermont Ferrand
Clermont-Ferrand, 63100, France
CHU Nantes
Nantes, 44000, France
Hopital Pitie Salpetriere
Paris, 75651, France
CHU Lyon Sud
Pierre-Bénite, 69495, France
CHU de Reims
Reims, 51100, France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, 67200, France
Semmelweis Egyetem
Budapest, 1088, Hungary
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024, Hungary
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
Nyíregyháza, 4400, Hungary
University of Szeged
Szeged, 6725, Hungary
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
Ferrara, 44124, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Ospedale San Raffaele
Milan, 20132, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Ospedale Maggiore della Carita
Novara, 28100, Italy
Universita degli Studi di Padova Azienda Ospedaliera di Pa
Padova, 35129, Italy
Ospedale Villa Sofia-Cervello
Palermo, 90146, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia, 06132, Italy
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, 00136, Italy
Umberto I Policlinico di Roma
Roma, 00161, Italy
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, 21 500, Poland
Szpital Specjalistyczny w Brzozowie
Brzozów, 36 200, Poland
Szpitale Pomorskie Sp z o o
Gdynia, 81-519, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, 30 688, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, 93 513, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20 090, Poland
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp Reina Sofia
Córdoba, 14004, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2023
First Posted
July 27, 2023
Study Start
May 30, 2024
Primary Completion (Estimated)
December 15, 2027
Study Completion (Estimated)
March 19, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu