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

• Status: Recruiting
• Trial end date: 2026-02-15
• Target enrollment: 0
• Participant gender: All

Summary

Phase 3 study to evaluate the efficacy and safety of dociparstat sodium in adults with newly diagnosed untreated AML with adverse or intermediate genetic risk.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chimerix
• Treatments: Heparin

Criteria

Inclusion Criteria:

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 to <60 years with adverse genetic risk, OR Age >=60 with intermediate or adverse genetic risk (according to ELN criteria).

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 if ≤79 years of age; ECOG status of 0 or 1 if ≥80 years of age.

Exclusion Criteria:

1. Acute promyelocytic leukemia (t(15;17)), myeloid sarcoma without bone marrow involvement, or blast transformation of chronic myelogenous leukemia.

2. AML with a history of antecedent myelodysplasia that has been previously-treated (e.g., with a hypomethylating agent).

3. Therapy-related AML after prior radiotherapy or chemotherapy for another cancer or disorder.

4. Clinical evidence of active central nervous system leukemia.

5. 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.

6. 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.

7. Treatment with any other investigational agent within 28 days, or 5 half-lives, whichever is longer, prior to baseline.

8. Any major surgery or radiation therapy within 28 days prior to baseline.

9. Immediately life threatening, severe complications of leukemia such as pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.

10. 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.

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

12. Active (uncontrolled, metastatic) second malignancy.

13. History of severe congestive heart failure or other cardiac disease that contraindicates the use of idarubicin or daunorubicin (e.g., cardiac ejection fraction <45%).

14. QTc >450 msec for a male, >470 msec for a female, or >480 msec if underlying bundle branch block.

15. Severe renal impairment, as determined by calculated creatinine clearance <30 mL/min or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.

16. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) or total bilirubin >2x ULN.