A Phase III Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Lymphoma/CLL (ONC)
Current Status: Open
Phase: III
Principal Investigator: Ananth, Snegha
Eligibility: https://clinicaltrials.gov/study/NCT06943872?term=NCT06943872&rank=1#participation-criteria
Summary
Primary:
-To compare the efficacy between Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab) as measured by progression-free survival (PFS).
Key Secondary:
-To compare the efficacy between Arm B (sonrotoclax plus rituximab) versus Arm D (venetoclax plus rituximab) as measured by PFS.
-To compare the efficacy between Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab) as measured by the uMRD rate at C14D1, complete response/complete response with incomplete hematopoietic recovery (CR/CRi), and overall survival (OS).
Secondary:
- To compare the efficacy of Arm B (sonrotoclax plus rituximab) versus Arm D (venetoclax plus rituximab).
- To evaluate the efficacy between Arm A (sonrotoclax plus obinutuzumab) versus Arm B (sonrotoclax plus rituximab).
- To evaluate the efficacy between Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab).
- To evaluate the efficacy between Arm C (sonrotoclax plus obinutuzumab MRD-guided) versus Arm D (venetoclax plus rituximab).
- To evaluate the efficacy of combination treatments in all arms in terms of overall response rate (ORR), duration of response (DOR), time to response (TTR), and time to next anti-CLL/SLL treatment (TTNT).
- To evaluate the rate of uMRD at various timepoints in all arms.
- To measure changes in the patient-reported disease- and treatment-specific symptoms and function and to compare the differences between Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab), between Arm B (sonrotoclax plus rituximab) versus Arm D (venetoclax plus rituximab), between Arm C (sonrotoclax plus obinutuzumab MRD-guided) versus Arm D (venetoclax plus rituximab), between Arm A (sonrotoclax plus obinutuzumab) versus Arm B (sonrotoclax plus rituximab)
- To evaluate the safety and tolerability of all arms.
Exploratory:
- To evaluate the pharmacokinetics of sonrotoclax.
- To evaluate the clinical outcomes in subgroup analyses based on prognostic biomarkers and prior therapy status
- To evaluate the uMRD rate at 10-4 (uMRD4), 10-5 (uMRD5), and 10-6 (uMRD6) sensitivity; MRD dynamics; and correlation of the uMRD rates with PFS and OS.
- To evaluate the changes of immune cell profile during and posttherapy.
- To evaluate patient-reported health-related quality of life (HRQoL).
- To evaluate the efficacy in all arms in terms of progression-free survival 2 (PFS2)