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 Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.

NCT Number	NCT03839771
Lead Sponsor	Stichting Hemato-Oncologie voor Volwassenen Nederland Collaborators: Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)
Conditions	Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
Enrollment	968 participants
Start Date	2019-03-01
Primary Completion	2027-04-17 (estimated)
Study Completion	2034-09-19 (estimated)
Updated on ClinicalTrials.gov	2024-10-02