Dociparstat (DSTAT) in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia (AML) (DASH AML)

Open to people ages 18 years and up

1. Newly diagnosed, previously untreated AML (according to World Health Organization criteria) with at least 20% blasts in the peripheral blood or bone marrow.
2. Age ≥ 18 with Intermediate or Adverse genetic risk (per ELN criteria).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

1. Acute promyelocytic leukemia (t(15;17)), myeloid sarcoma without bone marrow involvement, or blast transformation of chronic myelogenous leukemia.
2. Clinical evidence of active central nervous system leukemia.
3. AML treatment, including Vyxeos (CPX-351, liposomal cytarabine and daunorubicin), gemtuzumab ozogamicin, or any other prohibited concomitant AML therapy previously received or anticipated to start during the study.
4. Receiving any form of anticoagulant therapy (e.g., unfractionated heparin, low molecular weight heparin, coumadin, factor Xa inhibitors). Heparin flush of indwelling catheters is permitted.
5. Treatment with any other investigational agent within 28 days, or 5 half-lives, whichever is longer, prior to baseline.
6. Any major surgery or radiation therapy within 28 days prior to baseline.
7. Immediately life threatening, severe complications of leukemia such as pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
8. Active or uncontrolled bleeding at the time of randomization; a bleeding disorder, either inherited or caused by disease; history of known arterial-venous malformation, intracranial hemorrhage, or suspected or known cerebral aneurysm; or clinically significant gastrointestinal bleeding within the 3 weeks prior to randomization.

9. Presence of significant active or uncontrolled infection, including HIV or hepatitis B or C.

   10. Active (uncontrolled, metastatic) second malignancy. 11. History of severe congestive heart failure or other cardiac disease that

   contraindicates the use of idarubicin or daunorubicin (e.g., cardiac ejection fraction <45%).

   12. QTc >480 msec. 13. Severe renal impairment, as determined by calculated creatinine clearance <30 mL/min

   or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.

   14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of

   normal (ULN) or total bilirubin >2x ULN.