CELESTIAL-RRCLL: A Study for Relapsed/Refractory CLL/SLL

This study, called CELESTIAL-RRCLL, is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments (relapsed and/or refractory). It compares how well different drug combinations work: sonrotoclax plus obinutuzumab, or sonrotoclax plus rituximab, against venetoclax plus rituximab. All these drugs are given either by mouth (orally) or through a vein (intravenously). The main goal is to see if these new combinations can stop the cancer from growing or spreading for longer (progression-free survival). You could be eligible if you've had at least one prior treatment for CLL/SLL and meet other specific criteria. The study plans to enroll about 630 people.

Study design
This is an interventional study comparing different drug combinations. It plans to enroll 630 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome (progression-free survival) will be assessed for up to approximately 51 months.

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NCT06943872

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
BeOne Medicines
~630 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:SonrotoclaxObinutuzumabRituximabVenetoclax

At a glance

Recruiting sites
181 of 195 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
Measured over Up to approximately 51 months
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
195 sites across 73 states
Brazil14
Germany11
France9
Spain9
Italy8
United Kingdom7
New South Wales5
California4
  • Study Director · STUDY_DIRECTOR · BeOne Medicines

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Eligibility criteria

Inclusion

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

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
  • Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm DUp to approximately 51 months

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.