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.

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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.

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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 mLmin or estimated glomerular filtration rate (eGFR) <301.73 m2.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) or total bilirubin >2x ULN.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

9

Study ID:

NCT04571645

Recruitment Status:

Active, not recruiting

Sponsor:

Chimerix

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There are 14 Locations for this study

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UC Irvine Medical Center
Orange California, 92868, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Norton Cancer Institute, St. Matthews Campus
Louisville Kentucky, 40207, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Allina Health System / Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
New York Medical College
Hawthorne New York, 10595, United States
Mount Sanai School of Medicine
New York New York, 10029, United States
East Carolina University Vidant Medical Center
Greenville North Carolina, 27834, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
Spartanburg Medical Gibbs Cancer Center
Spartanburg South Carolina, 29303, United States
Baylor
Dallas Texas, 75246, United States
University of Utah / Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22903, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

9

Study ID:

NCT04571645

Recruitment Status:

Active, not recruiting

Sponsor:


Chimerix

How clear is this clinincal trial information?

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