Acute Myeloid Leukemia Clinical Trial
Dociparstat (DSTAT) in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia (AML) (DASH AML)
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed, previously untreated AML (according to World Health Organization criteria) with at least 20% blasts in the peripheral blood or bone marrow.
Age ≥ 18 with Intermediate or Adverse genetic risk (per ELN criteria).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria:
Acute promyelocytic leukemia (t(15;17)), myeloid sarcoma without bone marrow involvement, or blast transformation of chronic myelogenous leukemia.
Clinical evidence of active central nervous system leukemia.
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.
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.
Treatment with any other investigational agent within 28 days, or 5 half-lives, whichever is longer, prior to baseline.
Any major surgery or radiation therapy within 28 days prior to baseline.
Immediately life threatening, severe complications of leukemia such as pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
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.
Presence of significant active or uncontrolled infection, including HIV or hepatitis B or C.
Active (uncontrolled, metastatic) second malignancy.
History of severe congestive heart failure or other cardiac disease that contraindicates the use of idarubicin or daunorubicin (e.g., cardiac ejection fraction <45%).
QTc >480 msec.
Severe renal impairment, as determined by calculated creatinine clearance <30 mL/min or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) or total bilirubin >2x ULN.
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There are 14 Locations for this study
Orange California, 92868, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40207, United States
New Orleans Louisiana, 70112, United States
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55407, United States
Hawthorne New York, 10595, United States
New York New York, 10029, United States
Greenville North Carolina, 27834, United States
Canton Ohio, 44718, United States
Spartanburg South Carolina, 29303, United States
Dallas Texas, 75246, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22903, United States
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