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Leukemia, Lymphocytic, Chronic, B-CellPhase 2TAILORNCT05963074

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

A Phase 2 study testing Ibrutinib and Venetoclax in people with Leukemia, Lymphocytic, Chronic, B-Cell and Small Lymphocytic Lymphoma, run by Janssen Research & Development, LLC at 74 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ibrutinib and Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
74 sitesin 8 countries
Study dates
30 May 2024to 19 Mar 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

74 sites in 8 countries.

74 sites in 8 countries

United States32 sites

  • Boise VA Medical Center

    Boise, Idaho, 83702

  • The Oncology Institute Clinical Research

    Cerritos, California, 90703

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Renovatio Clinical

    El Paso, Texas, 79915

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Iowa City VA Health Care System

    Iowa City, Iowa, 52246

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • Virginia Cancer Specialists

    Manassas, Virginia, 20110

  • Mount Sinai Medical Center Campus

    Miami Beach, Florida, 33140-2948

  • Minnesota Oncology Hematology P A

    Minneapolis, Minnesota, 55404

  • The Oncology Institute

    North Miami Beach, Florida, 33169

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

  • Mid Florida Hematology Oncology

    Orange, Florida, 32763

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

  • SLO Oncology and Hematology Health Center

    San Luis Obispo, California, 93401

  • Providence Medical Foundation

    Santa Rosa, California, 95403

  • VA Puget Sound Healthcare System

    Seattle, Washington, 98108

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Renovatio Clinical 1

    The Woodlands, Texas, 77380

  • Texas Oncology-Gulf Coast

    The Woodlands, Texas, 77380

  • Northwest Cancer Specialists PC

    Vancouver, Washington, 98684

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • PIH Health Hospital

    Whittier, California, 90602

Other trials in United States

Italy11 sites

  • U.O. Ematologia Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna

    Ferrara, 44124

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Ospedale San Raffaele

    Milan, 20132

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ospedale Maggiore della Carita

    Novara, 28100

  • Universita degli Studi di Padova Azienda Ospedaliera di Pa

    Padova, 35129

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

    Perugia, 06132

  • Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore

    Roma, 00136

  • Umberto I Policlinico di Roma

    Roma, 00161

Other trials in Italy

Poland7 sites

  • Wojewodzki Szpital Specjalistyczny

    Biała Podlaska, 21 500

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, 36 200

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81-519

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30 688

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 513

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090

Other trials in Poland

Czechia6 sites

  • Fakultni nemocnice Brno

    Brno-Bohunice, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Ustav Hematologie A Krevni Transfuze

    Prague, 128 00

Other trials in Czechia

France6 sites

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63100

  • CHU Nantes

    Nantes, 44000

  • Hopital Pitie Salpetriere

    Paris, 75651

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Reims

    Reims, 51100

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67200

Other trials in France

Spain6 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1088

  • Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400

  • University of Szeged

    Szeged, 6725

Other trials in Hungary

Canada2 sites

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9

Other trials in Canada

About this study

Official title: 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).

Being tested
Ibrutinib, Venetoclax
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbrutinibDrug

    Also called JNJ-54179060, IMBRUVICA

    Ibrutinib capsules will be administered orally.

  • VenetoclaxDrug

    Also called VENCLEXTA, VENCLYXTO

    Venetoclax tablets will be administered orally.

Study groups in NCT05963074
Study groupRoleWhat they receive
Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+VenetoclaxExperimentalParticipants 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.
Receives: Drug: Ibrutinib; Drug: Venetoclax
Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+VenetoclaxExperimentalParticipants 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.
Receives: Drug: Ibrutinib; Drug: Venetoclax
Cohort 2a: Continuous Ibrutinib MonotherapyExperimentalParticipants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity.
Receives: Drug: Ibrutinib
Cohort 2b: Continuous Ibrutinib MonotherapyExperimentalParticipants 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.
Receives: Drug: Ibrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years

Secondary outcomes (15)

  1. 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.

    Measured: Up to 5 years

  2. 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.

    Measured: Up to 5 years

  3. 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.

    Measured: Up to 5 years

  4. Overall Survival (OS)

    OS is defined as the time from date of randomization to date of death from any cause.

    Measured: Up to 5 years

  5. 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.

    Measured: Up to 5 years

  6. 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.

    Measured: Up to 5 years

  7. 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.

    Measured: Up to 5 years

  8. Percentage of Participants with Rate of Discontinuation due to AEs

    Percentage of participants with rate of discontinuation due to AEs will be reported.

    Measured: Up to 5 years

  9. Percentage of Participants with Dose Reduction due AEs

    Percentage of participants with dose reduction due AEs will be reported.

    Measured: Up to 5 years

  10. Adherence Rates

    The adherence rate is defined as the percentage of total dose taken over the total dose prescribed.

    Measured: Up to 5 years

  11. 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.

    Measured: Up to 5 years

  12. 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.

    Measured: Up to 5 years

  13. 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.

    Measured: Up to 5 years

  14. 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.

    Measured: Up to 5 years

  15. 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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start30 May 2024
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion19 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05963074
Sponsor's protocol ID
54179060CLL2032
Other IDs
54179060CLL2032, 2023-504044-34-00, 2023
Acronym
TAILOR
Status last verified
Nov 2026
First submitted
19 Jul 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibrutinib and Venetoclax in people with Leukemia, Lymphocytic, Chronic, B-Cell and Small Lymphocytic Lymphoma, run by Janssen Research & Development, LLC at 74 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Italy, Poland, Czechia, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response Rate (ORR) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05963074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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