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
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford Cancer Institute | 94304-2205 | Palo Alto | California |
| Scripps Prebys Cancer Center | 92103-2106 | San Diego | California |
| Rocky Mountain Cancer Centers (Williams) Usor | 80012-5405 | Aurora | Colorado |
| Yale University, Yale Cancer Center | 06520-8028 | New Haven | Connecticut |
| Eastern Connecticut Hematology and Oncology | 06360-2700 | Norwich | Connecticut |
| Illinois Cancer Specialists (Niles) Usor | 60714-5905 | Niles | Illinois |
| Mary Bird Perkins Cancer Center | 70809-3738 | Baton Rouge | Louisiana |
| Dana Farber Cancer Institute | 02215-5418 | Boston | Massachusetts |
| The Cancer and Hematology Centers | 49503-2563 | Grand Rapids | Michigan |
| Mayo Clinic Rochester | 55905-0001 | Rochester | Minnesota |
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