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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 630
Last updated 2026-05-11
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
Interventions
- DRUG
-
Sonrotoclax
Administered orally
- DRUG
-
Administered intravenously
- DRUG
-
Administered intravenously
- DRUG
-
Administered Orally
Sponsors & Collaborators
-
German CLL Study Group
collaborator OTHER -
BeOne Medicines
lead INDUSTRY
Principal Investigators
-
Study Director · BeOne Medicines
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-11
- Primary Completion
- 2029-09-30
- Completion
- 2031-12-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Czechia
- Denmark
- France
- Germany
- Ireland
- Italy
- Netherlands
- New Zealand
- Poland
- South Korea
- Spain
- Sweden
- United Kingdom
Study Locations
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