Full TitleAn Expanded Access Program (EAP) for Ivosidenib (AG-120) Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation
The purpose of this study is to expand access to the investigational drug ivosidenib (AG-120) in patients with acute myeloid leukemia (AML) that came back or continued to grow despite standard therapy and which contains a mutation in the IDH1 gene. Ivosidenib blocks an abnormal form of the IDH1 protein, which is involved in cancer cell metabolism. IDH1 causes too much of a substance called 2-HG to be produced, which may make leukemia cells grow. Ivosidenib is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have AML that came back or continued to grow despite prior therapy.
- Patients must recover from the serious side effects of previous treatments before entering the study.
- In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
- This study is for patients age 12 and older.
For more information about this study and to inquire about eligibility, contact Dr. Eytan Stein at 212-639-3314.