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Purpose

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria - Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy - Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake - Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 - Adequate organ function

Exclusion Criteria

  • Known active prolymphocytic leukemia or currently suspected Richter's transformation - Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug - Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent - Known central nervous system involvement by CLL/SLL - Severe or debilitating pulmonary disease - Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Sonrotoclax plus Obinutuzumab 		Sonrotoclax and obinutuzumab will be administered in combination.
  • Drug: Sonrotoclax
    Administered orally
    Other names:
    • BGB-11417
  • Drug: Obinutuzumab
    Administered intravenously
    Other names:
    • Gazyva
Experimental
Arm B: Sonrotoclax plus Rituximab 		Sonrotoclax and rituximab will be administered in combination.
  • Drug: Sonrotoclax
    Administered orally
    Other names:
    • BGB-11417
  • Drug: Rituximab
    Administered intravenously
    Other names:
    • Rituxan
Experimental
Arm C: Sonrotoclax plus Obinutuzumab (MRD) 		Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).
  • Drug: Sonrotoclax
    Administered orally
    Other names:
    • BGB-11417
  • Drug: Obinutuzumab
    Administered intravenously
    Other names:
    • Gazyva
Active Comparator
Arm D: Venetoclax plus Rituximab 		Venetoclax and rituximab will be administered in combination.
  • Drug: Rituximab
    Administered intravenously
    Other names:
    • Rituxan
  • Drug: Venetoclax
    Administered Orally
    Other names:
    • Venclexta

Recruiting Locations

Uci Health Laguna Hills
Laguna Hills, California 92653

Chao Family Comprehensive Cancer Center
Orange, California 92868-3201

Stanford Cancer Institute
Palo Alto, California 94304-2205

Scripps Prebys Cancer Center
San Diego, California 92103-2106

Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado 80012-5405

Yale University, Yale Cancer Center
New Haven, Connecticut 06520-8028

Eastern Connecticut Hematology and Oncology
Norwich, Connecticut 06360-2700

Northwestern University
Chicago, Illinois 60611

Illinois Cancer Specialists (Niles) Usor
Niles, Illinois 60714-5905

University of Louisville, Brown Cancer Center
Louisville, Kentucky 40202

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809-3738

University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201-1544

Dana Farber Cancer Institute
Boston, Massachusetts 02215-5418

The Cancer and Hematology Centers
Grand Rapids, Michigan 49503-2563

Mayo Clinic Rochester
Rochester, Minnesota 55905-0001

Sidney Kimmel Comprehensive Cancer Center Washington Twp
Sewell, New Jersey 08080

Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065-6800

Clinical Research Alliance, Inc
Westbury, New York 11590-5119

University of North Carolina At Chapel Hill
Chapel Hill, North Carolina 27514-4220

Levine Cancer Center
Charlotte, North Carolina 28204-2990

Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157

Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio 45245-1995

Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon 97401

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033

Thomas Jefferson University
Philadelphia, Pennsylvania 19107-4216

Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania 15232-1309

Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
Chattanooga, Tennessee 37404

Tennessee Oncology
Nashville, Tennessee 37205

Texas Oncology Baylorcharles A Sammons Cancer Center
Dallas, Texas 75246-2003

Texas Oncology San Antonio Medical Center Usor
San Antonio, Texas 78240-5251

Texas Oncology Tyler
Tyler, Texas 75702-7522

Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington 98684-6930

More Details

NCT ID
NCT06943872
Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
1-877-828-5568
clinicaltrials@beonemed.com

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center