The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive \[IDH1m\]) and cannot receive treatment with intensive chemotherapy (IC).
Has untreated Acute Myeloid Leukemia (AML)
Have a documented IDH1 R132 gene-mutated disease
Have at least one of the following making yourself ineligible for intensive chemotherapy (IC): 75 years or older, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2, or any comorbidity that the investigator judges to be incompatible with IC including but not limited to severe cardiac or pulmonary disorder, creatinine clearance less than 45 mL/minute, or bilirubin greater than 1.5 times the upper limit of normal
Has adequate hepatic (liver) and renal (kidney) function
Has received any prior treatment for AML, with the exception of hydroxyurea or leukapheresis for white blood cell count control
Has received prior treatment with an IDH1 inhibitor
Is a woman who is pregnant or breastfeeding
Has an active, uncontrolled, systemic fungal, bacterial, or viral infection (including human immunodeficiency virus [HIV], active hepatitis B (HBV), or hepatitis C virus [HCV]) without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
Single group
Ivosidenib 500mg Oral Tablet
DrugProvided as tablets, taken orally as two 250mg tablets once daily.
Azacitidine
DrugAdministered subcutaneously (SC) or intravenously (IV) at a dose of 75mg/m2/day for 7 days, either consecutively on Days 1-7 or discontinuously for Days 1-5 and 8-9 of each cycle. The 7 days of administration will occur at the beginning of every 4 week-long cycle.
Number of Adverse Events (AEs)
Adverse events (AEs) will be graded according to the CTCAE v5.0
Number of Serious Adverse Events (SAEs)
Adverse events (AEs) will be graded according to the CTCAE v5.0
Differentiation Syndrome of Grade 2 or higher
Number of Adverse Events (AEs) leading to ivosidenib + azacitidine discontinuation
Event-free survival (EFS)
Proportion of patients who achieve a complete remission (CR)
Proportion of patients who achieve complete remission plus complete remission with partial hematologic recovery rate (CR + CRh)
Proportion of patients who achieve complete remission plus complete remission with incomplete hematologic recovery rate (CR + CRi)
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