Recruiting

Phase 3

Sonrotoclax vs. VenetoclaxA Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

Sponsor:

BeOne Medicines

Code:

NCT06943872

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sonrotoclax

Obinutuzumab

Rituximab

Venetoclax

Study Details

Brief summary:

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

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Study ID

NCT06943872

Start date

Jun 11, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

630 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Sonrotoclax plus Obinutuzumab

Sonrotoclax and obinutuzumab will be administered in combination.

experimental: Arm B: Sonrotoclax plus Rituximab

Sonrotoclax and rituximab will be administered in combination.

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).

active comparator: Arm D: Venetoclax plus Rituximab

Venetoclax and rituximab will be administered in combination.

Interventions

Sonrotoclax

Administered orally

Obinutuzumab

Administered intravenously

Rituximab

Administered intravenously

Venetoclax

Administered Orally

Primary outcome measure

Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D [ Time Frame: Up to approximately 51 months ]

Central Contacts and Locations

Central contacts

Study Director

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

Locations

Uci Health Laguna Hills

Recruiting

Laguna Hills, California, United States, 92653

Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868-3201

Stanford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304-2205

Scripps Prebys Cancer Center

Recruiting

San Diego, California, United States, 92103-2106

Rocky Mountain Cancer Centers (Williams) Usor

Recruiting

Aurora, Colorado, United States, 80012-5405

Yale University Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520-8028

Eastern Connecticut Hematology and Oncology

Recruiting

Norwich, Connecticut, United States, 06360-2700

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331-3609

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Illinois Cancer Specialists (Niles) Usor

Recruiting

Niles, Illinois, United States, 60714-5905

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242-1009

Mission Cancer and Blood

Recruiting

Waukee, Iowa, United States, 50263

University of Louisville, Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809-3738

The University of Maryland Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Beth Israel Deaconess Medical Center (Bidmc)

Recruiting

Boston, Massachusetts, United States, 02215-5400

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215-5418

The Cancer and Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49503-2563

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905-0001

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Sidney Kimmel Comprehensive Cancer Center Washington Twp

Recruiting

Sewell, New Jersey, United States, 08080

Christus St Vincent Regional Cancer Center

Recruiting

Santa Fe, New Mexico, United States, 87505

Memorial Sloan Kettering Cancer Center Mskcc

Recruiting

New York, New York, United States, 10065-6800

Optum Medical Care, Pc

Recruiting

Westbury, New York, United States, 11590-5119

University of North Carolina At Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514-4220

Levine Cancer Center

Recruiting

Charlotte, North Carolina, United States, 28204-2990

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Oncology Hematology Care Clinical Trials, Llc

Recruiting

Cincinnati, Ohio, United States, 45245-1995

Oncology Associates of Oregon Willamette Valley Cancer Center

Recruiting

Eugene, Oregon, United States, 97401

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107-4216

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Recruiting

Pittsburgh, Pennsylvania, United States, 15232-1309

Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37205

Texas Oncology Baylorcharles A Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246-2003

Texas Oncology San Antonio Medical Center Usor

Recruiting

San Antonio, Texas, United States, 78240-5251

Texas Oncology Tyler

Recruiting

Tyler, Texas, United States, 75702-7522

Swedish Medical Center Swedish Cancer Institute First Hill Campus

Recruiting

Seattle, Washington, United States, 98104

Northwest Cancer Specialist, Pc(Us Oncology Research)

Recruiting

Vancouver, Washington, United States, 98684-6930

Arthur Je Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

British Columbia Cancer Agency the Vancouver Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Cancercare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Newfoundland and Labrador Health Services

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Ciusss Nim Hscm

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

Recruiting

Québec, Canada, G1J 1Z4

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 24, 2026

Last verified

Mar, 2026

Keywords

B-cell lymphoma 2 inhibitor (BCL-2i)
CLL-RR1
German CLL Study Group

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-24.