After remission post-induction and consolidation, maintenance therapy by an ivosidenib and oral azacitidine combination is susceptible to improve the prevention of AML relapse, which remains a major issue in the study population. We assume that the combination of ivosidenib with oral azacitidine will not be less well tolerated than in combination with the subcutaneous form, therapeutic regimen authorized until progression or toxicity. Ivosidenib and Onureg®, being already authorized treatments, it has been decided to use the classic administration schedules and dosages in combination.
The primary objective of the study is to evaluate relapse free survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib.
Male or female ≥ 55 years of age at the time of signing informed consent
Patients with confirmation of newly diagnosed AML by 2022 WHO criteria
Presence of IDH1 R132 mutation at AML diagnosis
Achievement CR or CRi following induction therapy by intensive chemotherapy (according to ELN 2022, appendix 2), within 17 weeks prior to enrollment.
Acute promyelocytic leukemia (FAB M3) with t(15;17) or its molecular equivalents (PML::RARA)
AML associated with t(9;22) or molecular evidence of such a translocation
Prior BM or hematopoietic stem cell transplantation
CR/CRi following treatment with hypomethylating agents
French Innovative Leukemia Organisation
Lead sponsor
Servier Affaires Médicales
Collaborator