Isocitrate deshydrogenase1 mutation-positive (IDH1m) acute myeloid leukemia (AML)
Conditions
Brief summary
• Adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), AEs leading to ivosidenib + azacytidine discontinuation, AEs leading to ivosidenib or azacitidine interruption, AEs leading to ivosidenib or azacitidine dose reduction, AEs leading to death • Clinical laboratory anomalies assessed as AEs • Patients requiring transfusion (platelet and RBC) and number of units transfused • Rate of infections
Detailed description
• Event-free survival (EFS) • Complete remission (CR) • CR + CR with partial hematologic recovery (CRh) • CR + CR with incomplete hematologic recovery (CRi) • Duration of response (DOR) (overall and by response type) • Time to response (TTR) • Overall survival (OS), • Hematologic Malignancy-Patient-Reported outcome (HM-PRO) • Family Reported Outcome Measure (FROM-16) (for caregivers/family), • 5 level EuroQol 5-dimensions (EQ-5D-5L) • Length of hospital stay (LOS) • Outpatient visits • Emergency room (ER) visits • Proportion of days at home, • Molecular profiling method • Time to results • Allele subtypes • Co-mutation profiles
Interventions
DRUGVidaza 25 mg/ml powder for suspension for injection
Sponsors
Servier Affaires Medicales
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), AEs leading to ivosidenib + azacytidine discontinuation, AEs leading to ivosidenib or azacitidine interruption, AEs leading to ivosidenib or azacitidine dose reduction, AEs leading to death • Clinical laboratory anomalies assessed as AEs • Patients requiring transfusion (platelet and RBC) and number of units transfused • Rate of infections | — |
Secondary
| Measure | Time frame |
|---|---|
| • Event-free survival (EFS) • Complete remission (CR) • CR + CR with partial hematologic recovery (CRh) • CR + CR with incomplete hematologic recovery (CRi) • Duration of response (DOR) (overall and by response type) • Time to response (TTR) • Overall survival (OS), • Hematologic Malignancy-Patient-Reported outcome (HM-PRO) • Family Reported Outcome Measure (FROM-16) (for caregivers/family), • 5 level EuroQol 5-dimensions (EQ-5D-5L) • Length of hospital stay (LOS) • Outpatient visits • Emergency room (ER) visits • Proportion of days at home, • Molecular profiling method • Time to results • Allele subtypes • Co-mutation profiles | — |
Countries
Austria, Belgium, France, Greece, Hungary, Ireland, Italy, Netherlands, Portugal, Romania, Spain
Outcome results
None listed