Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07463768 | 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. | PHASE2 | NOT YET_RECRUITING | 60 | — | — | Sep 1, 2026 | Sep 1, 2030 | Mar 11, 2026 | 20 | France |
| NCT07392242 | A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia | PHASE2 | RECRUITING | 45 | — | — | Jan 27, 2026 | Jan 1, 2028 | Mar 6, 2026 | 7 | United States |
relapse-free-survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib
Event-free survival is defined as the time between date of treatment start to treatment failure (failure to achieve complete remission or \<5% bone marrow blasts), confirmed relapse or death.
| Arm | Type | Description |
|---|---|---|
| ivosidenib + Oral azacitidine | EXPERIMENTAL | cf intervention |
| Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone | EXPERIMENTAL | Patients will be initially treated with 7 days of azacitidine (IV or SC per institutional preference, 14 days of venetoclax and 14 days of Ivosidenib daily, days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter). |
| Name | Type | Description |
|---|---|---|
| Ivosidenib + oral azacitidine | DRUG | Subjects 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. |
| Ivosidenib | DRUG | Ivosidenib ( days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter) |
| Azacitidine | DRUG | Azacitidine (IV or SC per institutional preference, days 1 through 7) |
| Venetoclax | DRUG | Venetoclax (days 1 through 14) |
Inclusion Criteria: 1. Male or female ≥ 55 years of age at the time of signing informed consent 2. Patients with confirmation of newly diagnosed AML by 2022 WHO criteria 3. Presence of IDH1 R132 mutation at AML diagnosis 4. Achievement CR or CRi following induction therapy by intensive chemotherapy...