A multicenter, phase 2 randomized, open label study to evaluate the efficacy and security of zanubrutinib in combination with obinutuzumab in previously untreated patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (GELLC-10-ZANUBIO)

Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

The primary endpoint of the study is the complete response rate (CRR) with undetectable minimal residual disease (uMRD).

Overall response rate (ORR), including partial response with lymphocytosis., Progression-free survival (PFS), defined as the time from randomization until symptomatic disease progression (as defined by the updated iwCLL-guidelines) or death by any cause, whichever occurs first., Overall survival (OS), defined as the time between the day of randomization to death from any cause., Immunological recovery, Safety: type, frequency, and severity of adverse events (AEs) and relationship of AEs to zanubrutinib or the combination of zanubrutinib and obinutuzumab, including the assessment of tumour lysis syndrome., Potential predictive biomarkers of response to zanubrutinib and obinutuzumab and mechanisms of resistance in patients diagnosed with CLL [Visits: Baseline, cycle 20, and at progression].

No related papers found yet.

Spain