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

Sponsor score: 40

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

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

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

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.