Trial NCT06943872
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)
- Phase
- Phase 3
- Sponsor
- BeOne Medicines
- Conditions
- Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 2Performance status
* 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/SLLBrain metastases
* Severe or debilitating pulmonary disease
* Clinically significant cardiovascular diseaseCardiac
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Restrictions found (3)
- Brain metastasesOutrightexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0, 1, or 2
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center (Bidmc) · Boston, Suffolk County
- Dana Farber Cancer Institute · Boston, Suffolk County