for people ages 18 years and up (full criteria)
at UC Irvine UCLA
study started
completion around
Principal Investigator
by Gary Schiller (ucla)



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.

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dociparstat Sodium in Combination With Standard Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia


A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of dociparstat sodium in combination with standard intensive induction and consolidation chemotherapy for the treatment of newly-diagnosed AML patients.


Acute Myeloid Leukemia, AML, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Heparin, Dociparastat sodium, Dociparstat sodium (DSTAT)


You can join if…

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.

You CAN'T join if...

  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.


  • UC Irvine Medical Center
    Orange California 92868 United States
  • University of Utah / Huntsman Cancer Institute
    Salt Lake City Utah 84112 United States

Lead Scientist at University of California Health


in progress, not accepting new patients
Start Date
Completion Date
Phase 3 research study
Study Type
About 9 people participating
Last Updated