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Clinical Trials in Ireland / NCT06943872
Recruiting Phase 3

A 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)

NCT06943872 · tracked via the Priya Life Science Ireland tracker
Sponsor
BeOne Medicines
Phase
Phase 3
Started
2025-06-11
Last updated
2026-08-24

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

SonrotoclaxObinutuzumabRituximabVenetoclax

Sonrotoclax: Administered orally

Obinutuzumab: Administered intravenously

Rituximab: Administered intravenously

Venetoclax: Administered Orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (195)

FacilityCityRegionStatus
Uci Health Laguna Hills Laguna Hills California Recruiting
Chao Family Comprehensive Cancer Center Orange California Recruiting
Stanford Cancer Institute Palo Alto California Recruiting
Scripps Prebys Cancer Center San Diego California Recruiting
Rocky Mountain Cancer Centers (Williams) Usor Aurora Colorado Recruiting
Yale University Yale Cancer Center New Haven Connecticut Recruiting
Eastern Connecticut Hematology and Oncology Norwich Connecticut Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
Northwestern University Chicago Illinois Recruiting
Illinois Cancer Specialists (Niles) Usor Niles Illinois Recruiting
University of Iowa Hospitals and Clinics Iowa City Iowa Recruiting
Mission Cancer and Blood Waukee Iowa Recruiting
University of Louisville, Brown Cancer Center Louisville Kentucky Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Recruiting
The University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland Recruiting
Beth Israel Deaconess Medical Center (Bidmc) Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
The Cancer and Hematology Centers Grand Rapids Michigan Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Sidney Kimmel Comprehensive Cancer Center Washington Twp Sewell New Jersey Recruiting
Christus St Vincent Regional Cancer Center Santa Fe New Mexico Recruiting
Memorial Sloan Kettering Cancer Center Mskcc New York New York Recruiting
Optum Medical Care, Pc Westbury New York Recruiting
University of North Carolina At Chapel Hill Chapel Hill North Carolina Recruiting
Levine Cancer Center Charlotte North Carolina Recruiting
Atrium Health Wake Forest Baptist Winston-Salem North Carolina Recruiting
Oncology Hematology Care Clinical Trials, Llc Cincinnati Ohio Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center Eugene Oregon Recruiting
Penn State Milton S Hershey Medical Center Hershey Pennsylvania Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh) Pittsburgh Pennsylvania Recruiting
Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga Chattanooga Tennessee Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
Texas Oncology Baylorcharles A Sammons Cancer Center Dallas Texas Recruiting
Texas Oncology San Antonio Medical Center Usor San Antonio Texas Recruiting
Texas Oncology Tyler Tyler Texas Recruiting
Swedish Medical Center Swedish Cancer Institute First Hill Campus Seattle Washington Recruiting
Northwest Cancer Specialist, Pc(Us Oncology Research) Vancouver Washington Recruiting
Hospital Aleman Caba Argentina Recruiting

+ 155 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06943872 on ClinicalTrials.gov ↗ ← All trials in Ireland