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RecruitingLast updated:20 July 2023

AMLM23: This phase III trial is investigating the safety and effectiveness of two types of targeted therapy in patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)A placebo controlled study to compare ivosidenib or enasidenib in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome

Clinical summary

Summary

Eligible patients will receive up to two cycles of induction therapy, up to three cycles of consolidation therapy and maintenance treatment. Across the three treatments, patients will be randomly selected to receive a placebo (no treatment) or oral Enasidenib or Ivosidenaib once a day for the whole induction cycle, until the end of consolidation and for up to two years maintenance.

Age

People18+

Phase

III

Trial Acronym

AMLM23

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Trial Identifiers

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Commercial Sponsor

Leukaemia Foundation

Scientific Title

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

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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Clinical trials have complex eligibility criteria.

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