RecruitingPhase 2NCT05963074

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

Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia

Sponsor

Janssen Research & Development, LLC

Enrollment

320 participants

Start Date

May 30, 2024

Study Type

INTERVENTIONAL

Conditions

Small Lymphocytic Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ibrutinib — a targeted oral therapy for blood cancer — can be customized into different treatment combinations for people newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Different groups will test ibrutinib alone, with venetoclax, or with other agents to find the best personalized approach. **You may be eligible if...** - You have been newly diagnosed with CLL or SLL (not yet treated) - Your diagnosis meets standard international diagnostic criteria - Your overall health is adequate for treatment (ECOG performance status 0–2) - You are 18 or older **You may NOT be eligible if...** - You have already received treatment for CLL/SLL - You have a 17p deletion or TP53 mutation (for certain study groups) - You have serious heart problems, liver disease, or other major health conditions that make ibrutinib unsafe - You are currently taking certain medications that interact with ibrutinib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIbrutinib

Ibrutinib capsules will be administered orally.

DRUGVenetoclax

Venetoclax tablets will be administered orally.

Locations(73)

The Oncology Institute Clinical Research

Cerritos, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

SLO Oncology and Hematology Health Center

San Luis Obispo, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

PIH Health Hospital

Whittier, California, United States

Grand Valley Oncology

Grand Junction, Colorado, United States

Mount Sinai Medical Center Campus

Miami Beach, Florida, United States

The Oncology Institute

North Miami Beach, Florida, United States

Mid Florida Hematology Oncology

Orange, Florida, United States

Boise VA Medical Center

Boise, Idaho, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Iowa City VA Health Care System

Iowa City, Iowa, United States

Minnesota Oncology Hematology P A

Minneapolis, Minnesota, United States

Research Medical Center

Kansas City, Missouri, United States

Hunterdon Hematology Oncology

Flemington, New Jersey, United States

Summit Medical Group

Florham Park, New Jersey, United States

Hematology Oncology Associates of Rockland

Nyack, New York, United States

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Renovatio Clinical 1

The Woodlands, Texas, United States

Texas Oncology-Gulf Coast

The Woodlands, Texas, United States

Community Cancer Trials of Utah

Ogden, Utah, United States

Virginia Cancer Specialists

Manassas, Virginia, United States

Virginia Oncology Associates

Virginia Beach, Virginia, United States

VA Puget Sound Healthcare System

Seattle, Washington, United States

Northwest Cancer Specialists PC

Vancouver, Washington, United States

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Niagara Health System

St. Catharines, Ontario, Canada

Fakultni nemocnice Brno

Brno-Bohunice, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni Nemocnice Ostrava

Ostrava - Poruba, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Ustav Hematologie A Krevni Transfuze

Prague, Czechia

CHU de Clermont Ferrand

Clermont-Ferrand, France

CHU Nantes

Nantes, France

Hopital Pitie Salpetriere

Paris, France

CHU Lyon Sud

Pierre-Bénite, France

CHU de Reims

Reims, France

Institut de Cancerologie Strasbourg Europe ICANS

Strasbourg, France

Semmelweis Egyetem

Budapest, Hungary

Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Győr, Hungary

Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

Nyíregyháza, Hungary

University of Szeged

Szeged, Hungary

U.O. Ematologia Istituto Tumori Giovanni Paolo II

Bari, Italy

Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna

Ferrara, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Ospedale San Raffaele

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Ospedale Maggiore della Carita

Novara, Italy

Universita degli Studi di Padova Azienda Ospedaliera di Pa

Padova, Italy

Ospedale Villa Sofia-Cervello

Palermo, Italy

Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia

Perugia, Italy

Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore

Roma, Italy

Umberto I Policlinico di Roma

Roma, Italy

Wojewodzki Szpital Specjalistyczny

Biała Podlaska, Poland

Szpital Specjalistyczny w Brzozowie

Brzozów, Poland

Szpitale Pomorskie Sp z o o

Gdynia, Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, Poland

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, Poland

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Reina Sofia

Córdoba, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain

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NCT05963074

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