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Clinical trial for newly diagnosed AML or MDS with IDH1 or IDH2 mutation

Assoc. Prof. Paula Marlton
Trial Lead Assoc. Professor Paula Marlton

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 leukemia 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 leukemias harboring 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.

The clinical trial will recruit approximately 80 Australian patients. The expected timeline for the recruitment of patients is 2020 to 2024.

For more information about current clinical trials, visit the ALLG website.

Learn more about this trial in our interview with Paula Marlton >