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
Single group
Ivosidenib + oral azacitidine
DrugSubjects will be administered treatment over 28-day cycles until progression or another reason (unacceptable toxicity, patient choice to discontinue study treatment, sponsor decision, HSCT at any time, patients who require the use of any of the excluded therapies). The treatment is the association of ivosidenib with oral azacitidine. * The investigational medicinal product is ivosidenib. Two tablets (500 mg) will be administered as a single dose, once daily, during 28 days-cycles until discontinuation. * The auxiliary treatment is oral azacitidine. Oral AZA 300 mg will be given once-daily for 14 days of repeated 28-day treatment cycles. For all patients, oral AZA will be interrupted systematically after day 14 of each 28-days cycle.
RFS 24 months
relapse-free-survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib
RFS 12 months
RFS at 12 months, with the same definition for RFS as for the primary endpoint
Overall survival
Overall survival defined as the time between inclusion assignment and death from any cause, at 12 and 24 months
EFS MRD neg
EFS MRD-, defined in patients who were MRD negative at baseline to MRD relapse (by FCM or RT-qPC for NPM1) or death from any cause, whichever occurred first
TEAEs
Number of participants with Treatment Emergent Adverse Events (TEAEs), according the CTCAE v5.0 classification
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French Innovative Leukemia Organisation
Lead sponsor
Servier Affaires Médicales
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
