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

NCT ID NCT05963074

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

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 4 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.

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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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