Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML

Required: IL3RA overexpression (no minimum threshold for positivity)

Expression of CD123 by either flow cytometry or immunohistochemical staining with no minimum threshold for positivity

Allowed: IDH1 mutation

If mutations in the IDH or FLT3 genes, treatment with IDH or FLT3 inhibitors after initial failure of venetoclax plus HMA is allowed, but not required.

Allowed: IDH2 mutation

If mutations in the IDH or FLT3 genes, treatment with IDH or FLT3 inhibitors after initial failure of venetoclax plus HMA is allowed, but not required.

Allowed: FLT3 mutation

If mutations in the IDH or FLT3 genes, treatment with IDH or FLT3 inhibitors after initial failure of venetoclax plus HMA is allowed, but not required.

Must have received: venetoclax plus hypomethylating agent (venetoclax, azacitidine, decitabine) — initial therapy

Must have received initial therapy with venetoclax in combination with a hypomethylating agent (either azacitidine or decitabine) with no subsequent therapy unless mutations in the IDH or FLT3 genes.

Cannot have received: any therapy apart from Venetoclax in combination with a hypomethylating agent, or Venetoclax in combination with a hypomethylating agent followed by monotherapy with IDH or FLT3 inhibitors

Prior therapy apart from Venetoclax in combination with a hypomethylating agent, or Venetoclax in combination with a hypomethylating agent followed by monotherapy with IDH or FLT3 inhibitors

Cannot have received: systemic anti-cancer therapy

Exception: hydroxyurea allowed during first cycle if needed for disease control

Patients who received systemic anti-cancer therapy <14 days prior to their first day of study drug administration. Concurrent hydroxyurea will be allowed. Hydroxyurea use will be allowed only during the first cycle if needed for disease control.

Cannot have received: allogenic stem cell transplant

Received allogenic stem cell transplant prior to the treatment.