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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)

NCT06943872

RecruitingPhase 3

Sponsor: BeOne Medicines

Conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Interventions: Sonrotoclax, Obinutuzumab, Rituximab, Venetoclax

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (195)

Laguna Hills, California, United States
Orange, California, United States
Palo Alto, California, United States
San Diego, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Norwich, Connecticut, United States
Weston, Florida, United States
Chicago, Illinois, United States
Niles, Illinois, United States
Iowa City, Iowa, United States
Waukee, Iowa, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
Sewell, New Jersey, United States
Santa Fe, New Mexico, United States
New York, New York, United States
Westbury, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Eugene, Oregon, United States
Hershey, Pennsylvania, United States
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