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)
About this study
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.
- Condition
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Tested
- Sonrotoclax, Obinutuzumab, Rituximab, Venetoclax
- Sponsor
- BeOne Medicines
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- 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 7
- 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.
Where
195 sites, 181 recruiting
Hospital Aleman
Caba, Argentina
FUNDALEU
Caba, Argentina
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, Argentina
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
and 189 more sites on ClinicalTrials.gov
Contact
-
Study Director
1-877-828-5568 clinicaltrials@beonemed.com
Potential match only. Final eligibility is determined by the study team.