RECRUITING

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

Talk to us

Conditions

Leukemia, Lymphocytic, Chronic, B-CellSmall Lymphocytic Lymphoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-01-31
Study Completion:2029-03-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05963074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria
  2. * 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
  3. * 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
  4. * A participant using oral contraceptives must use an additional contraceptive method
  5. * 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)
  1. * 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
  2. * Known bleeding disorders (example, von Willebrand's disease or hemophilia)
  3. * Stroke or intracranial hemorrhage within 6 months prior to enrollment
  4. * Known or suspected Richter's transformation or central nervous system (CNS) involvement
  5. * 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

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

The Oncology Institute Clinical Research
Cerritos, California, 90703
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
United States
SLO Oncology and Hematology Health Center
San Luis Obispo, California, 93401
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
PIH Health Hospital
Whittier, California, 90602
United States
Grand Valley Oncology
Grand Junction, Colorado, 81505
United States
Mount Sinai Medical Center Campus
Miami Beach, Florida, 33140-2948
United States
The Oncology Institute
North Miami Beach, Florida, 33169
United States
Boise VA Medical Center
Boise, Idaho, 83702
United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Iowa City VA Health Care System
Iowa City, Iowa, 52246
United States
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, 55404
United States
Research Medical Center
Kansas City, Missouri, 64132
United States
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822
United States
Summit Medical Group
Florham Park, New Jersey, 07932
United States
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
United States
Oncology Hematology Care
Cincinnati, Ohio, 45242
United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
United States
OHSU Knight Cancer Institute
Portland, Oregon, 97239
United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, 76104
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology-Gulf Coast
The Woodlands, Texas, 77380
United States
Community Cancer Trials of Utah
Ogden, Utah, 84405
United States
Virginia Cancer Specialists
Gainesville, Virginia, 20155
United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456
United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108
United States
Northwest Cancer Specialists PC
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31
Study Completion Date2029-03-19

Study Record Updates

Study Start Date2024-01-31
Study Completion Date2029-03-19

Terms related to this study

Additional Relevant MeSH Terms

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