Clinical trial for newly diagnosed AML or MDS with IDH1 or IDH2 mutation
ALLG clinical trial AMLM23: A study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukaemia or myelodysplastic syndrome with excess blasts-2, with an IDH1 or IDH2 mutation, respectively, eligible for intensive chemotherapy
Trial Lead: Assoc. Professor Paula Marlton
AMLM23 is an international Phase III, multicentre, double-blind, randomized, placebo-controlled study.
Mutations in isocitrate dehydrogenase 1 (IDH1) and isocitrate dehydrogenase 2 (IDH2) are observed in approximately 20% of patients with newly diagnosed AML (cumulative percentage for both mutations). The rationale of the current study is that addition of drugs specifically designed to target leukaemia’s harbouring these mutations may improve treatment outcome in newly diagnosed patients when combined with standard induction and consolidation therapy and when given as maintenance therapy thereafter. The drugs investigated in this study are ivosidenib (AG-120) and enasidenib (AG-221), which are potent inhibitors of the IDH1 and IDH2 mutant proteins, respectively.
Ten patients have already been recruited to the trial at hospital sites in Townsville, Melbourne, Perth and Sydney, with plans for the trial to open at a total 20 sites across Australia and recruit a total 80 patients over four years.