Patients over 55 with Acute Myeloid Leukemia (AML) and IDH1 mutation, in complete remission after intensive chemotherapy.
Conditions
Brief summary
Relapse-free-survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib.
Detailed description
RFS at 12 months, with the same definition for RFS as for the primary endpoint., Overall survival defined as the time between inclusion assignment and death from any cause, at 12 and 24 months. Patients alive will be censored at the date of last news, or data cutoff., EFS MRD-, defined in patients who were MRD negative at baseline as the time from inclusion to MRD relapse (by FCM or RT-qPC for NPM1) or death from any cause, whichever occurred first. Patients alive without MRD relapse will be censored at the date of last MRD assessment., Number of participants with Treatment Emergent Adverse Events (TEAEs), according the CTCAE v5.0 classification.
Interventions
Sponsors
French Innovative Leukemia Organization
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free-survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib. | — |
Secondary
| Measure | Time frame |
|---|---|
| RFS at 12 months, with the same definition for RFS as for the primary endpoint., Overall survival defined as the time between inclusion assignment and death from any cause, at 12 and 24 months. Patients alive will be censored at the date of last news, or data cutoff., EFS MRD-, defined in patients who were MRD negative at baseline as the time from inclusion to MRD relapse (by FCM or RT-qPC for NPM1) or death from any cause, whichever occurred first. Patients alive without MRD relapse will be censored at the date of last MRD assessment., Number of participants with Treatment Emergent Adverse Events (TEAEs), according the CTCAE v5.0 classification. | — |
Countries
France
Outcome results
None listed