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AMLM26/T5- INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in Acute Myeloid Leukaemia (AML)): A Multi-arm, Precision-based, Recursive, Platform Trial - MBG453 OR MBG453 and Azacitidine
Australasian Leukaemia and Lymphoma Group (ALLG)
This is a sub-porotocl for the multi-arm INTERCEPT trial (master protocol can be found by searching ACTRN12621000439842). Eligible participants will be randomly allocated to one of two treatment arms. In Treatment Arm A, participants will receive MBG453 (via intravenous infusion) at a dose of 800mg on Day 1 of a 28 day cycle. In Treatment Arm B, participants will receive azacitidine (subcutaneously or intravenously) at a dose of 75mg/m2 on days 1-8, and MGB453 (intravenously) at a dose of 800mg on day 8. Azacitidine will be given from days 1-7 or using the 5-2-2 schedule with MGB453 on day 8 out of a 28-day cycle. Both treatment arms will be given for 12 cycles.