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

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).

Study Overview

• Status: Recruiting
• Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: Ibrutinib; Drug: Venetoclax

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Recruiting
      • QEII Health Sciences Centre
  • Ontario
    • St. Catharines, Ontario, Canada, L2S 0A9
      • Recruiting
      • Niagara Health System
• Czechia
  • Brno-Bohunice, Czechia, 625 00
    • Recruiting
    • Fakultní nemocnice Brno
  • Hradec Králové, Czechia, 500 05
    • Recruiting
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Fakultni nemocnice Olomouc
  • Ostrava - Poruba, Czechia, 708 52
    • Recruiting
    • Fakultni nemocnice Ostrava
  • Prague, Czechia, 100 34
    • Recruiting
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 128 00
    • Recruiting
    • Ustav Hematologie A Krevni Transfuze
• France
  • Clermont-Ferrand, France, 63100
    • Completed
    • CHU de Clermont Ferrand
  • Nantes, France, 44000
    • Recruiting
    • CHU Nantes
  • Paris, France, 75651
    • Recruiting
    • Hôpital Pitie Salpétrière
  • Pierre-Bénite, France, 69495
    • Recruiting
    • CHU Lyon Sud
  • Reims, France, 51100
    • Recruiting
    • CHU de Reims
  • Strasbourg, France, 67200
    • Completed
    • Institut de Cancerologie Strasbourg Europe ICANS
• Hungary
  • Budapest, Hungary, 1088
    • Recruiting
    • Semmelweis Egyetem
  • Győr, Hungary, 9024
    • Recruiting
    • Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
  • Nyíregyháza, Hungary, 4400
    • Recruiting
    • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
  • Szeged, Hungary, 6725
    • Recruiting
    • University of Szeged
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • U.O. Ematologia Istituto Tumori Giovanni Paolo II
  • Ferrara, Italy, 44124
    • Recruiting
    • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
  • Florence, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero Universitaria Careggi
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Milan, Italy, 20162
    • Recruiting
    • ASST Grande Ospedale Metropolitano Niguarda
  • Novara, Italy, 28100
    • Recruiting
    • Ospedale Maggiore della Carità
  • Padova, Italy, 35129
    • Recruiting
    • Universita degli Studi di Padova Azienda Ospedaliera di Pa
  • Palermo, Italy, 90146
    • Recruiting
    • Ospedale Villa Sofia-Cervello
  • Perugia, Italy, 06132
    • Recruiting
    • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
  • Roma, Italy, 00161
    • Recruiting
    • Umberto I Policlinico di Roma
  • Roma, Italy, 00136
    • Recruiting
    • Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
• Poland
  • Biała Podlaska, Poland, 21 500
    • Recruiting
    • Wojewodzki Szpital Specjalistyczny
  • Brzozów, Poland, 36 200
    • Recruiting
    • Szpital Specjalistyczny w Brzozowie
  • Gdynia, Poland, 81-519
    • Recruiting
    • Szpitale Pomorskie Sp z o o
  • Kielce, Poland, 25 734
    • Recruiting
    • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
  • Krakow, Poland, 30 688
    • Recruiting
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
  • Lodz, Poland, 93 513
    • Recruiting
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
  • Lublin, Poland, 20 090
    • Recruiting
    • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hosp Univ Vall D Hebron
  • Córdoba, Spain, 14004
    • Recruiting
    • Hosp Reina Sofia
  • Madrid, Spain, 28034
    • Recruiting
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Santander, Spain, 39008
    • Recruiting
    • Hosp. Univ. Marques de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Hosp. Clinico Univ. de Santiago
• United States
  • California
    • Cerritos, California, United States, 90703
      • Recruiting
      • The Oncology Institute Clinical Research
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Cancer and Blood Specialty Clinic
    • San Luis Obispo, California, United States, 93401
      • Recruiting
      • SLO Oncology and Hematology Health Center
    • Santa Rosa, California, United States, 95403
      • Recruiting
      • Providence Medical Foundation
    • Whittier, California, United States, 90602
      • Recruiting
      • PIH Health Hospital
  • Colorado
    • Grand Junction, Colorado, United States, 81505
      • Recruiting
      • Grand Valley Oncology
  • Florida
    • Miami Beach, Florida, United States, 33140-2948
      • Recruiting
      • Mount Sinai Medical Center Campus
    • North Miami Beach, Florida, United States, 33169
      • Recruiting
      • The Oncology Institute
    • Orange, Florida, United States, 32763
      • Recruiting
      • Mid Florida Hematology Oncology
  • Idaho
    • Boise, Idaho, United States, 83702
      • Recruiting
      • Boise VA Medical Center
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Recruiting
      • Hope and Healing Cancer Services
    • Springfield, Illinois, United States, 62702
      • Recruiting
      • Springfield Clinic
  • Iowa
    • Iowa City, Iowa, United States, 52246
      • Recruiting
      • Iowa City VA Health Care System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Minnesota Oncology Hematology P A
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Recruiting
      • Research Medical Center
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Recruiting
      • Hunterdon Hematology Oncology
    • Florham Park, New Jersey, United States, 07932
      • Completed
      • Summit Medical Group
  • New York
    • Nyack, New York, United States, 10960
      • Recruiting
      • Hematology Oncology Associates of Rockland
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Completed
      • Southeastern Medical Oncology Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Oncology Hematology Care
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Willamette Valley Cancer Institute and Research Center
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
  • Texas
    • El Paso, Texas, United States, 79915
      • Completed
      • Renovatio Clinical
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Texas Oncology-Fort Worth Cancer Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
    • The Woodlands, Texas, United States, 77380
      • Recruiting
      • Texas Oncology-Gulf Coast
    • The Woodlands, Texas, United States, 77380
      • Completed
      • Renovatio Clinical 1
  • Utah
    • Ogden, Utah, United States, 84405
      • Recruiting
      • Community Cancer Trials of Utah
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Recruiting
      • Virginia Cancer Specialists
    • Virginia Beach, Virginia, United States, 23456
      • Recruiting
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98108
      • Recruiting
      • VA Puget Sound Healthcare System
    • Vancouver, Washington, United States, 98684
      • Recruiting
      • Northwest Cancer Specialists PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax; Participants 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.	Drug: Ibrutinib; Ibrutinib capsules will be administered orally.; Other Names: JNJ-54179060, IMBRUVICA; Drug: Venetoclax; Venetoclax tablets will be administered orally.; Other Names: VENCLEXTA, VENCLYXTO
Experimental: Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax; Participants 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.	Drug: Ibrutinib; Ibrutinib capsules will be administered orally.; Other Names: JNJ-54179060, IMBRUVICA; Drug: Venetoclax; Venetoclax tablets will be administered orally.; Other Names: VENCLEXTA, VENCLYXTO
Experimental: Cohort 2a: Continuous Ibrutinib Monotherapy; Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.	Drug: Ibrutinib; Ibrutinib capsules will be administered orally.; Other Names: JNJ-54179060, IMBRUVICA
Experimental: Cohort 2b: Continuous Ibrutinib Monotherapy; Participants 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.	Drug: Ibrutinib; Ibrutinib capsules will be administered orally.; Other Names: JNJ-54179060, IMBRUVICA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) Rate	CR rate is defined as the percentage of participants achieving a best overall response of CR or CRi per iwCLL 2018 criteria as assessed by investigator.	Up to 5 years
Duration of Response (DOR)	DOR is defined as the duration in days from the date of initial documentation of PR or better to the date of first documented evidence of PD or death.	Up to 5 years
Progression Free Survival (PFS)	PFS by investigator assessment is defined as the duration from date of randomization to date of PD or death due to any cause, whichever occurs first.	Up to 5 years
Overall Survival (OS)	OS is defined as the time from date of randomization to date of death from any cause.	Up to 5 years
Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate	MRD-negative rate is defined as the percentage of participants who reach MRD-negative status (that is, less than [<] 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes or <0.01 percentage [%]) in the peripheral blood.	Up to 5 years
Number of Participants with Adverse Events (AEs)	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 5 years
Number of Participants with AEs by Severity	An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.	Up to 5 years
Percentage of Participants with Rate of Discontinuation due to AEs	Percentage of participants with rate of discontinuation due to AEs will be reported.	Up to 5 years
Percentage of Participants with Dose Reduction due AEs	Percentage of participants with dose reduction due AEs will be reported.	Up to 5 years
Adherence Rates	The adherence rate is defined as the percentage of total dose taken over the total dose prescribed.	Up to 5 years
Duration of Treatment	Duration of treatment is defined as the time period in days between the date of first study treatment administration and date of last administration.	Up to 5 years
Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)	Time to worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by EQ-5D-5L will be reported.	Up to 5 years
Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)	Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-C30 will be reported.	Up to 5 years
Time to Worsening as Measured by EORTC QLQ-CLL17	Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-CLL17 will be reported.	Up to 5 years
Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score	Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by FACIT-fatigue total score will be reported.	Up to 5 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Collaborators: Pharmacyclics LLC.
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): March 19, 2029

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; venetoclax; ibrutinib
• Other Study ID Numbers: 54179060CLL2032 (Other Identifier: Janssen Research & Development, LLC); 2023-504044-34-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No