The researchers are doing this study to find out whether a 3-drug combination of ivosidenib, azacitidine, and venetoclax followed by maintenance therapy with ivosidenib alone is an effective treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH mutation. Maintenance therapy is additional treatment given to help keep cancer from coming back after it has disappeared following the first course of treatment. The researchers will also look at the safety of the treatment approach and what kind of a time commitment it involves for participants.
Participant must be at least 60 years of age at the time of signing the informed consent form (ICF).
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
Participant has newly diagnosed AML as per World Health Organization 2022 or European leukemia Network 2022 guidelines.
Participant has IDH1-R132 mutation present prior to initiating Ivo/Aza/Ven confirmed by CLIA approved local testing via next-generation sequencing (NGS) and/or polymerase chain reaction (PCR). Other 2-HG producing IDH1 variants may be eligible after discussion with MSK principal investigator.
Participant with acute promyelocytic leukemia
Participants who have previously received ivosidenib or venetoclax
Participant receiving any other investigational anti-cancer agents. Cytoreductive therapy such as hydroxyurea is permitted.
Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
Single group
Ivosidenib
DrugIvosidenib ( days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter)
Azacitidine
DrugAzacitidine (IV or SC per institutional preference, days 1 through 7)
Venetoclax
DrugVenetoclax (days 1 through 14)
Event free survival
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.
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Servier Pharmaceuticals, LLC
Collaborator
