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NCT05963074 | RECRUITING | Leukemia, Lymphocytic, Chronic, B-Cell

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

Janssen Research & Development, LLC

Brief 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).

Condition or disease

Leukemia, Lymphocytic, Chronic, B-Cell

Small Lymphocytic Lymphoma

Intervention/treatment

Ibrutinib

Venetoclax

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 320 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients With Previously Untreated Chronic Lymphocytic Leukemia
Actual Study Start Date : 2024-05-30
Estimated Primary Completion Date : 2028-09-29
Estimated Study Completion Date : 2029-03-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

Location Details

NCT05963074

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

The Oncology Institute Clinical Research

Cerritos, California, United States, 90703

RECRUITING

United States, California

Cancer and Blood Specialty Clinic

The Alamitos, California, United States, 90720

RECRUITING

United States, California

SLO Oncology and Hematology Health Center

San Luis Bishop, California, United States, 93401

RECRUITING

United States, California

Providence Medical Foundation

Santa Rosa, California, United States, 95403

RECRUITING

United States, California

PIH Health Hospital

Whittier, California, United States, 90602

RECRUITING

United States, Colorado

Grand Valley Oncology

Grand Junction, Colorado, United States, 81505

RECRUITING

United States, Florida

Mount Sinai Medical Center Campus

Miami Beach, Florida, United States, 33140-2948

RECRUITING

United States, Florida

The Oncology Institute

North Miami Beach, Florida, United States, 33169

RECRUITING

United States, Florida

Mid Florida Hematology Oncology

Orange, Florida, United States, 32763

RECRUITING

United States, Idaho

Boise VA Medical Center

Boise, Idaho, United States, 83702

RECRUITING

United States, Illinois

Hope and Healing Cancer Services

Hinsdale, Illinois, United States, 60521

RECRUITING

United States, Illinois

Springfield Clinic

Springfield, Illinois, United States, 62702

RECRUITING

United States, Iowa

Iowa City VA Health Care System

Iowa City, Iowa, United States, 52246

RECRUITING

United States, Minnesota

Minnesota Oncology Hematology P A

Minneapolis, Minnesota, United States, 55404

RECRUITING

United States, Missouri

Research Medical Center

Kansas City, Missouri, United States, 64132

RECRUITING

United States, New Jersey

Hunterdon Hematology Oncology

Flemington, New Jersey, United States, 08822

COMPLETED

United States, New Jersey

Summit Medical Group

Florham Park, New Jersey, United States, 07932

RECRUITING

United States, New York

Hematology Oncology Associates of Rockland

Nyack, New York, United States, 10960

COMPLETED

United States, North Carolina

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States, 27534

RECRUITING

United States, Ohio

Oncology Hematology Care

Cincinnati, Ohio, United States, 45242

RECRUITING

United States, Oregon

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States, 97401

RECRUITING

United States, Oregon

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97239

RECRUITING

United States, Texas

Updated clinical

The step, Texas, United States, 79915

RECRUITING

United States, Texas

Texas Oncology-Fort Worth Cancer Center

Fort Worth, Texas, United States, 76104

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

Updated clinical

The Woodlands, Texas, United States, 77380

RECRUITING

United States, Texas

Texas Oncology-Gulf Coast

The Woodlands, Texas, United States, 77380

RECRUITING

United States, Utah

Community Cancer Trials of Utah

Ogden, Utah, United States, 84405

RECRUITING

United States, Virginia

Virginia Cancer Specialists

Manassas, Virginia, United States, 20110

RECRUITING

United States, Virginia

Virginia Oncology Associates

Virginia Beach, Virginia, United States, 23456

RECRUITING

United States, Washington

VA Puget Sound Healthcare System

Seattle, Washington, United States, 98108

RECRUITING

United States, Washington

Northwest Cancer Specialists PC

Vancouver, Washington, United States, 98684

RECRUITING

Canada, New Scotia

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada, B3H 1V7

RECRUITING

Canada, Ontario

Niagara Health System

St. Catharines, Ontario, Canada, L2S 0A9

RECRUITING

Czechia,

Faculty hospital Brno

Brno - Bohunice, Czechia, 625 00

RECRUITING

Czechia,

Faculty Hospital Hradec Kralove

Hradec Kralove, Czechia, 500 05

RECRUITING

Czechia,

Faculty Hospital Olomouc

Olomouc, Czechia, 779 00

RECRUITING

Czechia,

Faculty Hospital Ostrava

Ostrava - Poruba, Czechia, 708 52

RECRUITING

Czechia,

Faculty Hospital Kralovské Vinohrady

Prague 10, Czechia, 100 34

RECRUITING

Czechia,

The installation of hematology and blood transfusion

Prague 2, Czechia, 128 00

RECRUITING

France,

Chu the clemont ferrand

Clermont-Ferrand, France, 63100

RECRUITING

France,

Chu nantes

Nantes Cedex 1, France, 44000

RECRUITING

France,

Hopital drinking salpetriere

Paris Cedex 13, France, 75651

RECRUITING

France,

CHU Lyon Sud

Pierre-Benite, France, 69495

RECRUITING

France,

Reims of chu

Reims, France, 51100

RECRUITING

France,

Strasbourg Europe Icans Cancerology Institute

Strasbourg, France, 67200

RECRUITING

Hungary,

Semmelweis University

Budapest, Hungary, 1088

RECRUITING

Hungary,

Gyor Moson Sopron Varmegyei Petz Aladar University Education

Gyor, Hungary, 9024

RECRUITING

Hungary,

Szabolcs Szatmar Bereg Varmegye Education

Birch, Hungary, 4400

RECRUITING

Hungary,

University of Szeged

Szeged, Hungary, 6725

RECRUITING

Italy,

U.O. Hematology Institute Tumors John Paul II

Bari, Italy, 70124

RECRUITING

Italy,

Hospital-University of Ferrara Arcisanno Sant Anna

Ferrara, Italy, 44124

RECRUITING

Italy,

Careggi University Hospital

Firenze, Italy, 50134

RECRUITING

Italy,

San Raffaele Hospital

Milano, Italy, 20132

RECRUITING

Italy,

ASST Grande Metropolitan Hospital Niguarda

Milano, Italy, 20162

RECRUITING

Italy,

Maggiore della Carita hospital

Novara, Italy, 28100

RECRUITING

Italy,

Padua University of Padua Hospital of PA

Padova, Italy, 35129

RECRUITING

Italy,

Villa Sofia-Cervello hospital

Palermo, Italy, 90146

RECRUITING

Italy,

Hospital of Perugia Hospital S.Maria della Misericordia

Perugia, Italy, 06132

RECRUITING

Italy,

Ematology Foundation Univ. Polyclinic Gemelli Catholic University of the Sacred Heart

Roma, Italy, 00136

RECRUITING

Italy,

Umberto the Polyclinic of Rome

Roma, Italy, 00161

RECRUITING

Poland,

Voivodship Specialist Hospital

White Podlasie, Poland, 21 500

RECRUITING

Poland,

Specialist Hospital in Brzozów

Birch, Poland, 36 200

RECRUITING

Poland,

Pomorskie Hospitals SP Z O O

Gdynia, Poland, 81-519

RECRUITING

Poland,

Swietokrzyskie Oncology Center SPZOZ in Kielce

Kielce, Poland, 25 734

RECRUITING

Poland,

Independent Public Health Care Institution. University Hospital in Krakow

Krakow, Poland, 30 688

RECRUITING

Poland,

Voivodship multi -specialist Center of Oncology and Traumatology Im M Copernicus in Lodz

Lodz, Poland, 93 513

RECRUITING

Poland,

The Oncology Center of the Lublin Region of SW Jan from Dukla

Lublin, Poland, 20 090

RECRUITING

Spain,

Hosp Vall d Hebron

Barcelona, Spain, 08035

RECRUITING

Spain,

Reina Sofia Hospital

Cordoba, Spain, 14004

RECRUITING

Spain,

Hosp. Univ. Ramon and Cajal

Madrid, Spain, 28034

RECRUITING

Spain,

Hosp. UNIV. October 12

Madrid, Spain, 28041

RECRUITING

Spain,

Hosp. Univ. Marques de Valdecilla

Santander, Spain, 39008

RECRUITING

Spain,

Hosp. CLINIC UNIV. DE SANTIAGO

Santiago de Compostela, Spain, 15706