A Phase II Study of IDH1 Inhibition With Ivosidenib as Maintenance Therapy After Ivosidenib, Azacitidine, and Venetoclax for Acute Myeloid Leukemia
Summary
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.
Arms & interventions
- DrugIvosidenib
Ivosidenib ( days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter)
- DrugAzacitidine
Azacitidine (IV or SC per institutional preference, days 1 through 7)
- DrugVenetoclax
Venetoclax (days 1 through 14)
Outcome measures
Primary
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.
Time frame: 12 months
Eligibility criteria
Study locations (7)
Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553