This study is comparing the efficacy of two different combinations of targeted therapies in people with chronic lymphocytic leukaemiaA Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Summary

Eligible participants will be randomly allocated to one of two treatment arms. Both arms will receive a combination of targeted therapy. Treatment cycles are 28 days.

In the Experimental Arm, participants will receive Sonrotoclax plus Zanubrutinib. Participants will receive, from the start of Cycle 1, a standard dose of oral zanubrutinib once or twice daily, and in combination with oral sonrotoclax starting from Cycle 4 onwards at increasing doses until the target dose is reached and continuing until end of Cycle 15.

In the Active Comparator Arm, participants will receive Venetoclax plus Obinutuzumab. Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900mg on Day 2 Cycle 1 (or alternatively receive 1000mg intravenously on Day 1) followed by 1000mg on Days 8 and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2 through 6 in combination with oral venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12. 

Conditions

This trial is treating patients with chronic lymphocytic leukaemia who have not had prior treatment

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