A placebo controlled study to compare ivosidenib or enasidenib in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

Abstract

The purpose of this study is to investigate the efficacy and safety of Ivosidenib and Enasidenib in patients with acute myeloid Leukaemia or myelodysplastic syndrome (MDS).

Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with AML or MDS with either an IDH1 or IDH2 mutation, with no previous chemotherapy treatment.

Study details Participants in this study will receive the following treatments:

1.Up to two cycles of Induction: Cytarabine for 6 days and Daunorubicin once a day for 3 days through an infusion in the vein. You will be randomly assigned either a placebo (no treatment) or Enasidenib or Ivosidenaib orally with a tablet once a day for the whole cycle.

2.Up to three cycles of consolidation: Cytarabine twice a day through an infusion in the vein over 3 days. You may then receive either a placebo (no treatment) or Enasidenib or Ivosidenaib orally with a tablet once a day until the end of consolidation.

3.Maintenance treatment will be either a placebo (no treatment), Enasidenib or Ivosidenaib for up to two years.

All participants will undertake blood tests, bone marrow biopsies, scans and questionnaires.