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)

Sponsor: BeiGene

Sponsor score: 40

ClinicalTrials ID:NCT06943872

This study evaluates the efficacy and safety of sonrotoclax with obinutuzumab or rituximab versus venetoclax with rituximab in adults with R/R CLL/SLL. Eligible participants must have a confirmed CLL/SLL diagnosis, prior therapy, and adequate organ function. Interventions include oral sonrotoclax and venetoclax, and intravenous obinutuzumab and rituximab.

Patient Parameters

Program Overview

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.

Eligibility 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.

Locations

FACILITYZIPCITYSTATE
Stanford Cancer Institute94304-2205Palo AltoCalifornia
Scripps Prebys Cancer Center92103-2106San DiegoCalifornia
Rocky Mountain Cancer Centers (Williams) Usor80012-5405AuroraColorado
Yale University, Yale Cancer Center06520-8028New HavenConnecticut
Eastern Connecticut Hematology and Oncology06360-2700NorwichConnecticut
Illinois Cancer Specialists (Niles) Usor60714-5905NilesIllinois
Mary Bird Perkins Cancer Center70809-3738Baton RougeLouisiana
Dana Farber Cancer Institute02215-5418BostonMassachusetts
The Cancer and Hematology Centers49503-2563Grand RapidsMichigan
Mayo Clinic Rochester55905-0001RochesterMinnesota

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