This project will investigate the potential risks and benefits of adding a targeted therapy called ziftomenib to intensive therapy (7+3) with cytarabine consolidation and seeing if the use of ziftomenib as maintenance therapy following consolidation is beneficial.
Ziftomenib is currently being studied as a possible treatment for patients with AML with NPM1-mutation and KMT2A-rearrangement because it is known to target the menin pathway.
The use of ziftomenib with 7+3/consolidation and as maintenance therapy to treat AML is “investigational.” This means that the combination of all three drugs has not been approved for use outside of research projects by regulatory (government) authorities including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or your country's competent Health Authority.
The purpose of this project is:
To see if ziftomenib combined with 7+3/cytarabine consolidation/maintenance is better than 7+3/cytarabine consolidation alone at improving your AML.
To see if ziftomenib combined with 7+3/cytarabine consolidation/maintenance can make you live longer than 7+3/cytarabine consolidation alone.
To study the side effects of ziftomenib when taken with 7+3/cytarabine consolidation/maintenance.
To determine how long ziftomenib stays in your blood stream and how your body breaks it down.
To evaluate the additional effects of ziftomenib on your body.
To evaluate if ziftomenib combined with 7+3 improves your AML symptoms (fatigue, your physical and mental well-being).
To study why your AML might or might not respond to treatment with ziftomenib in combination with 7+3/cytarabine.