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RecruitingLast updated: 27 November 2025

CELESTIAL-RRCLL: This study is recruiting people with relapsed and/or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) to compare the effectiveness of two combination treatmentsA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

CELESTIAL-RRCLL

Clinical summary

Summary

The goal of this study is to compare how well sonrotoclax plus rituximab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL). 

Eligible participants will be randomly allocated to one of four arms where they will receive the following treatments:

  • Arm A: oral sonrotoclax plus intravenous (IV) obinutuzumab
  • Arm B: oral sonrotoclax plus IV rituximab
  • Arm C: oral sonrotoclax plus IV obinutuzumab with treatment guided by evaluation of minimal residual disease (MRD)
  • Arm D: oral venetoclax plus IV rituximab

Conditions

This trial is treating people with chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received one or more prior treatments

Eligibility

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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BeiGene

Scientific Title

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

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