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Can lower doses of ibrutinib still control CLL? new trial aims to find out

NCT ID NCT05963074

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This phase 2 study is testing whether adjusting the dose of ibrutinib—either by starting lower or reducing it when side effects occur—can still effectively control chronic lymphocytic leukemia (CLL) in people who have not yet been treated. Some participants will receive ibrutinib alone, while others will get ibrutinib combined with venetoclax. The goal is to see if these customized regimens maintain disease control while being easier to tolerate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ibrutinib and venetoclax
What this could lead to
If successful, this could show that adjusting ibrutinib doses based on side effects is as effective as standard dosing, making treatment more tolerable for CLL patients.
What could go wrong
This is a phase 2 trial with 320 participants, so results are still preliminary. The dose adjustments might reduce effectiveness or fail to improve tolerability as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

333 people

The number who actually took part.

Started

May 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, lymphocytic, chronic, B-cell Small lymphocytic lymphoma

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

    Perugia, 06132, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna

    Ferrara, 44124, Italy

  • Boise VA Medical Center

    Boise, Idaho, 83702, United States

  • CHU Lyon Sud

    Pierre-Bénite, 69495, France

  • CHU Nantes

    Nantes, 44000, France

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63100, France

  • CHU de Reims

    Reims, 51100, France

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720, United States

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090, Poland

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

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

    Roma, 00136, Italy

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52, Czechia

  • Fakultni nemocnice Brno

    Brno-Bohunice, 625 00, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Grand Valley Oncology

    Grand Junction, Colorado, 81505, United States

  • Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024, Hungary

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960, United States

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521, United States

  • Hopital Pitie Salpetriere

    Paris, 75651, France

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822, United States

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67200, France

  • Iowa City VA Health Care System

    Iowa City, Iowa, 52246, United States

  • Mid Florida Hematology Oncology

    Orange, Florida, 32763, United States

  • Minnesota Oncology Hematology P A

    Minneapolis, Minnesota, 55404, United States

  • Mount Sinai Medical Center Campus

    Miami Beach, Florida, 33140-2948, United States

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9, Canada

  • Northwest Cancer Specialists PC

    Vancouver, Washington, 98684, United States

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239, United States

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242, United States

  • Ospedale Maggiore della Carita

    Novara, 28100, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146, Italy

  • PIH Health Hospital

    Whittier, California, 90602, United States

  • Providence Medical Foundation

    Santa Rosa, California, 95403, United States

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Renovatio Clinical

    El Paso, Texas, 79915, United States

  • Renovatio Clinical 1

    The Woodlands, Texas, 77380, United States

  • Research Medical Center

    Kansas City, Missouri, 64132, United States

  • SLO Oncology and Hematology Health Center

    San Luis Obispo, California, 93401, United States

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30 688, Poland

  • Semmelweis Egyetem

    Budapest, 1088, Hungary

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534, United States

  • Springfield Clinic

    Springfield, Illinois, 62702, United States

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734, Poland

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400, Hungary

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, 36 200, Poland

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81-519, Poland

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104, United States

  • Texas Oncology-Gulf Coast

    The Woodlands, Texas, 77380, United States

  • The Oncology Institute

    North Miami Beach, Florida, 33169, United States

  • The Oncology Institute Clinical Research

    Cerritos, California, 90703, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • U.O. Ematologia Istituto Tumori Giovanni Paolo II

    Bari, 70124, Italy

  • Umberto I Policlinico di Roma

    Roma, 00161, Italy

  • Universita degli Studi di Padova Azienda Ospedaliera di Pa

    Padova, 35129, Italy

  • University of Szeged

    Szeged, 6725, Hungary

  • Ustav Hematologie A Krevni Transfuze

    Prague, 128 00, Czechia

  • VA Puget Sound Healthcare System

    Seattle, Washington, 98108, United States

  • Virginia Cancer Specialists

    Manassas, Virginia, 20110, United States

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456, United States

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401, United States

  • Wojewodzki Szpital Specjalistyczny

    Biała Podlaska, 21 500, Poland

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

    Lodz, 93 513, Poland

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Other studies related to the condition(s) this trial covers.