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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571645
Recruitment Status : Active, not recruiting
First Posted : October 1, 2020
Last Update Posted : June 16, 2022
Sponsor:
Information provided by (Responsible Party):
Chimerix

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Dociparastat sodium Other: Placebo Phase 3

Detailed 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Dociparstat sodium (DSTAT)
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Dociparstat 4 mg/kg IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Dociparstat 0.25 mg/kg/hr via continuous IV infusion 24 hours daily for 5 or 7 days.
Drug: Dociparastat sodium
Dociparstat is a glycosaminoglycan derived from porcine heparin.
Other Names:
  • DSTAT
  • CX-01
  • 2-0,3-0 desulfated heparin
  • ODSH

Placebo Comparator: Placebo
Treatment with standard intensive induction, reinduction, or consolidation chemotherapy and Placebo IV bolus on Day 1, administered 30 minutes after completion of the first dose of idarubicin or daunorubicin, followed by Placebo via continuous IV infusion 24 hours daily for 5 or 7 days.
Other: Placebo
0.9% Normal Saline
Other Names:
  • 0.9% Normal Saline
  • Normal saline
  • Sodium chloride 0.9%




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Measured from randomization up to 5 years ]
    Overall survival is defined as time until death from any cause, through 5 years.


Secondary Outcome Measures :
  1. Event free survival [ Time Frame: Measured from randomization up to 5 years ]
    Event free survival (EFS) is defined as time to induction/reinduction treatment failure (within 42 days), relapse after complete remission (CR), or death from any cause.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 with Intermediate or Adverse genetic risk (per ELN criteria).
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571645


Locations
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United States, California
UC Irvine Medical Center
Orange, California, United States, 92868
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Allina Health System / Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, New York
New York Medical College
Hawthorne, New York, United States, 10595
Mount Sanai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
East Carolina University Vidant Medical Center
Greenville, North Carolina, United States, 27834
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, South Carolina
Spartanburg Medical Gibbs Cancer Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Baylor
Dallas, Texas, United States, 75246
United States, Utah
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Chimerix
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Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT04571645    
Other Study ID Numbers: CMX-DS-003
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chimerix:
AML
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action