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.

Eligibility

Age range

60+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Ivosidenib

  Ivosidenib ( days 15 through 28 for cycle 1, then days 1 through 28 for each cycle thereafter)

• Drug
  Azacitidine

  Azacitidine (IV or SC per institutional preference, days 1 through 7)

• Drug
  Venetoclax

  Venetoclax (days 1 through 14)

Locations (7)