MiRisten for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Must have received: any available therapy known to be active for AML

relapsed or refractory (R/R) disease who have failed treatment with, or are ineligible for, available therapies known to be active for treatment of AML

Cannot have received: allogeneic hematopoietic stem cell transplant

Exception: allowed if >3 months prior to day 1 of protocol therapy and off calcineurin inhibitors for at least 2 weeks

Allogeneic hematopoietic stem cell transplant within 3 months prior to day 1 of protocol therapy. Patients must be off calcineurin inhibitors for at least 2 weeks prior to day 1 of protocol therapy.

Cannot have received: chemotherapy

Exception: hydroxyurea permitted

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy, with the exception of hydroxyurea.

Cannot have received: radiation therapy

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy, with the exception of hydroxyurea.

Cannot have received: biological therapy

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy, with the exception of hydroxyurea.

Cannot have received: immunotherapy

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy, with the exception of hydroxyurea.