ACTIVE_NOT_RECRUITING

Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

Talk to us

Conditions

CLLChronic Lymphocytic Leukemia

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 main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

Official Title

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Quick Facts

Study Start:2023-11-11
Study Completion:2032-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06073821

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. * Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
  2. * Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
  3. * Measurable disease by Computer Tomography/Magnetic Resonance Imaging
  4. * Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN
  5. * Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute
  1. * Previous systemic treatment for CLL
  2. * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  3. * Known central nervous system involvement
  4. * History of confirmed progressive multifocal leukoencephalopathy (PML)
  5. * Uncontrolled hypertension

Contacts and Locations

Study Locations (Sites)

Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974
United States
City of Hope National Medical Center
Duarte, California, 91010-3012
United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, 92093-1503
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067-2011
United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, 90095-3075
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
United States
Stanford Medicine
Palo Alto, California, 94304-2205
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045-2517
United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2113
United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140-2840
United States
Moffitt Cancer Center
Tampa, Florida, 33612-9496
United States
Southeastern Regional Medical Center
Newnan, Georgia, 30265-8001
United States
Northwestern University
Chicago, Illinois, 60611
United States
Illinois Cancercare, Pc
Peoria, Illinois, 61615-7822
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
United States
Mission Cancer and Blood
Waukee, Iowa, 50263
United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205-2003
United States
Norton Cancer Institute Pavilion
Louisville, Kentucky, 40207-4700
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2429
United States
University of Minnesota
Minneapolis, Minnesota, 55455-0341
United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010
United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601-2191
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901-1914
United States
Columbia University Medical Center
New York, New York, 10032
United States
Clinical Research Alliance, Inc
Westbury, New York, 11590-5119
United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514-4220
United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204-2990
United States
Duke University Medical Center
Durham, North Carolina, 27705-3976
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001
United States
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio, 43210-1240
United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2434
United States
Scri Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404-1130
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
Virginia Cancer Institute
Richmond, Virginia, 23229-8605
United States
Vcu Health Systemmassey Comprehensive Cancer Center
Richmond, Virginia, 23298-5004
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433
United States
Gunderson Health System
La Crosse, Wisconsin, 54601-5467
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-1222
United States

Collaborators and Investigators

Sponsor: BeOne Medicines

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 Date2023-11-11
Study Completion Date2032-12

Study Record Updates

Study Start Date2023-11-11
Study Completion Date2032-12

Terms related to this study

Keywords Provided by Researchers

  • CLL
  • Chronic Lymphocytic Leukemia

Additional Relevant MeSH Terms

  • CLL