Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onure… (NCT07463768) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.
France60 participantsStarted 2026-09
Plain-language summary
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.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Received at least 2 consolidations :
✓. with intermediate dose of cytarabine (IDAC)
✓. or with standard dose cytarabine and idarubicin (5+1)
✓. Adequate BM function: ANC ≥1 × 109/L and platelet count ≥50 × 109/L at the time of inclusion
Exclusion criteria
✕. 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
✕. Proven central nervous system leukemia
✕. Candidate for Allo-HSCT at screening
✕. Diagnosis of malignant disease within the previous 12 months (excluding MDS or CMML, basal cell carcinoma of the skin without complications, "in- situ" carcinoma of the cervix or breast, or other local malignancy excised or irradiated with a high probability of cure)
✕. Abnormal cardiac status with any of the following: