An Expanded Access Program for Ivosidenib (AG-120) in Patients with Recurrent or Persistent Acute Myeloid Leukemia with an IDH1 Mutation

Full Title

An Expanded Access Program (EAP) for Ivosidenib (AG-120) Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation

Purpose

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).

Eligibility

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.

Protocol

17-550

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators