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Comparing sonrotoclax combinations versus venetoclax plus rituximab for relapsed or refractory CLL/SLL

A 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

Phase 3 Interventional BeOne Medicines · NCT06943872

This trial will test whether sonrotoclax combined with obinutuzumab or with rituximab works better than venetoclax plus rituximab for adults whose CLL/SLL has come back or not responded to prior treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment630 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionschimeric antigen receptor, obinutuzumab, rituximab, rituxumab
Locations170 sites (Laguna Hills, California and 169 other locations)
Trial IDNCT06943872 on ClinicalTrials.gov

What this trial studies

This randomized phase 3 trial compares two sonrotoclax-containing regimens (sonrotoclax plus obinutuzumab and sonrotoclax plus rituximab) against the established venetoclax plus rituximab regimen in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. The primary outcome is progression-free survival, and the study will also monitor safety and tolerability of the combinations. Eligible participants must meet iwCLL diagnostic criteria, have had at least one prior therapy, and have ECOG performance status 0–2 with adequate organ function; limited prior BCL-2 inhibitor exposure is permitted under specific timing and remission conditions. Treatments are administered at specialized cancer centers with scheduled clinical and laboratory follow-up.

Who should consider this trial

Good fit: Adults with relapsed or refractory CLL/SLL who meet iwCLL criteria, have received one or more prior therapies (each at least two cycles), have ECOG 0–2, and adequate organ function are ideal candidates, with prior BCL-2 inhibitor exposure allowed only if remission lasted ≥3 years and at least 2 years have passed since last BCL-2i use.

Not a fit: Patients with known active prolymphocytic leukemia or suspected Richter's transformation, recent autologous transplant or CAR-T within 3 months, active graft-versus-host disease after allogeneic transplant, or known central nervous system involvement are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, these sonrotoclax combinations could extend the time patients live without their disease getting worse compared with the current venetoclax-based option.

How similar studies have performed: Venetoclax plus anti-CD20 antibodies has shown efficacy in relapsed CLL/SLL, while sonrotoclax is a newer BCL-2 inhibitor with more limited clinical data in these combinations to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Laguna Hills, California and 169 other locations

+120 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaB-cell lymphoma 2 inhibitorCLL-RR1German CLL Study Group
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.