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

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)

Conditions

CLL

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Study Overview

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Study Details

Study overview

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)

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

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

Condition
CLL
Intervention / Treatment

-

Contacts and Locations

Anchorage

Alaska Oncology and Hematology, Llc, Anchorage, Alaska, United States, 99508

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Orange

Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868

Stanford

Stanford Medicine, Stanford, California, United States, 94305

Aurora

University of Colorado Cancer Center, Aurora, Colorado, United States, 80014

Miami Beach

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States, 33140

Newnan

Southeastern Regional Medical Center, Newnan, Georgia, United States, 30265

Peoria

Illinois Cancercare, Pc, Peoria, Illinois, United States, 61615

Fort Wayne

Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States, 46804

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
  • * Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
  • * Measurable disease by Computer Tomography/Magnetic Resonance Imaging
  • * 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
  • * Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute
  • * Previous systemic treatment for CLL
  • * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • * Known central nervous system involvement
  • * History of confirmed progressive multifocal leukoencephalopathy (PML)
  • * Uncontrolled hypertension

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Record Dates

2032-12