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A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia
Gilead Sciences, Inc.
This is a randomised, open-label trial with one Experimental Arm and two Active Comparator Arms. In the Experimental Arm, participants will receive an escalating dose of magrolimab (administered intravenously [via IV]) and a fixed dose of azacitidine (administered either via an injection or via IV, 75mg/m^2 on Days 1-7 or Days 1-5,8 and 9 during every cycle). The first Active Comparator Arm will consist of participants who are appropriate for non-invasive therapy. They will receive an escalating dose of venetoclax (administered orally, 100mg on Day 1, 200mg on Day 2, 400mg on Days 3-28 during Cycle 1, followed by 400mg on Days 1-28 during every cycle thereafter), and a fixed dose of azacitidine (administered the same as in the Experimental Arm). The second Active Comparator Arm will consist of participants who are appropriate for intensive therapy. They will receive 7+3 chemotherapy: 7 day treatment with cytarabine and a 3 day treatment with daunorubicin or idarubicin during induction and high-dose cytarabine and steroidal eye drops during consolidation. Cytarabine will be administered (during induction) as a continuous infusion, 100 or 200mg/m^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle. Cytarabine will be administered (during consolidation) via IV, 3000mg/m^2 on Days 1, 3 and 5 once every 12 hours for up to 4 cycles. Daunorubicin will be administered via IV peripherally, 60mg/m^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle. Idarubicin will be administered via IV, 12mg/m^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle.