Study on Sonrotoclax with Obinutuzumab or Rituximab Compared to Venetoclax with Rituximab for Treating Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Sponsor: BeiGene
ClinicalTrials ID:NCT06943872
This clinical trial is comparing the effectiveness of two new treatment combinations for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned or not responded to previous treatments. The study will also evaluate the safety of these treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to see how well two different treatment combinations work for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to previous treatments. The study will compare the combination of sonrotoclax with obinutuzumab against venetoclax with rituximab, and also sonrotoclax with rituximab against venetoclax with rituximab. Researchers will also look at the safety of these treatments.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) based on specific medical criteria.
- Have received at least one previous treatment for CLL/SLL, with at least two cycles per treatment.
- If previously treated with BCL2 inhibitors, must have had a remission lasting at least 3 years, with at least 2 years since the last BCL2 inhibitor treatment.
- Be in relatively good overall health, with a performance status score between 0 and 2, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have active prolymphocytic leukemia or suspected transformation to a more aggressive form of lymphoma (Richter's transformation).
- Have had a stem cell transplant or CAR-T cell therapy within the last 3 months.
- Have had a stem cell transplant from a donor and currently have active graft-versus-host disease (GVHD) or are taking medications to treat GVHD.
- Have cancer that has spread to the central nervous system.
- Have severe lung disease.
- Have significant heart disease.
Note: Other specific 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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