Recruiting

Sonrotoclax and Anti-CD20 Antibody in Relapsed/Refractory CLL/SLL

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What is being tested

Sonrotoclax

+ Obinutuzumab

+ Rituximab

Drug
Who is being recruted

Chronic Disease+13

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorBeOne Medicines
Study ContactStudy Director
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 11, 2025

Actual date on which the first participant was enrolled.

This study is a Phase 3 trial exploring the effectiveness of Sonrotoclax combined with Anti-CD20 Antibody Therapies compared to Venetoclax plus Rituximab in patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. The goal is to find a better treatment option for these patients. The importance of this study lies in its potential to improve care for those with this specific type of leukemia or lymphoma who have not responded well to previous treatments or have experienced a relapse. During the study, participants are randomly assigned to one of two treatment groups. One group receives Sonrotoclax plus Anti-CD20 Antibody Therapies, while the other group receives Venetoclax plus Rituximab. The primary outcome measured is Progression-Free Survival (PFS), which is defined as the time from the start of the study until the disease worsens or the participant passes away, whichever happens first. This measurement helps determine how well the treatments are working.

Official TitleA Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT06943872
Principal SponsorBeOne Medicines
Study ContactStudy Director
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

630 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellDisease Attributes

Criteria

1 inclusion criteria required to participate
Participants with prior BCL2i exposure are eligible if remission duration was >= 3 years with >= 2 years from last BCL2i intake

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Sonrotoclax and obinutuzumab will be administered in combination.

Group II

Experimental
Sonrotoclax and rituximab will be administered in combination.

Group III

Experimental
Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).

Group IV

Active Comparator
Venetoclax and rituximab will be administered in combination.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 155 locations

Recruiting

Eastern Connecticut Hematology and Oncology

Norwich, United StatesOpen Eastern Connecticut Hematology and Oncology in Google Maps
Recruiting

Northwestern University

Chicago, United States
Recruiting

Iuct Oncopole

Toulouse, France
Recruiting

Freeman Hospital

Newcastle upon Tyne, United Kingdom
Recruiting
155 Study Centers
Sonrotoclax and Anti-CD20 Antibody in Relapsed/Refractory CLL/SLL | PatLynk