A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia

Previously Untreated Chronic Lymphocytic Leukemia

Best CR/CRi rate up to the first Post-Treatment Follow-up (PTFU1) Visit for Arm A and up to the C16D1 Visit for Arm B per Independent Review Committee (IRC) response assessment using the 2018 International Workshop on Chronic Lymphocytic Leukemia (Hallek et al 2018) guidelines with modification for treatment-related lymphocytosis (Cheson et al 2012) for patients with CLL

uMRD4 rate measured in both peripheral blood and bone marrow aspirate at PTFU 1 Visit for Arm A and at C16D1 Visit for Arm B based on next-generation sequencing (NGS) (clonoSEQ®), • CR/CRi rate per investigator response assessment • ORR per IRC and investigator response assessment • Landmark DOR event-free rate at 12 months per IRC response assessment • DOR per investigator response assessment • TTR per IRC and investigator response assessment • Landmark PFS rate at 24 months and overall PFS per investigator response assessment • OS, Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 and the iwCLL Grading Scale for Hematologic Toxicities in CLL Studies as appropriate. Tumor lysis syndrome (TLS) will be monitored per Howard criteria.

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