Clinical Trials /

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

NCT04571645

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CMX-DS-003
  • NCT ID: NCT04571645

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
Dociparastat sodiumDSTAT, CX-01, 2-0,3-0 desulfated heparin, ODSHDociparstat sodium (DSTAT)

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Dociparstat sodium (DSTAT)ExperimentalTreatment 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.
  • Dociparastat sodium
PlaceboPlacebo ComparatorTreatment 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.

    Eligibility 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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Overall survival
    Time Frame:Measured from randomization up to 5 years
    Safety Issue:
    Description:Overall survival is defined as time until death from any cause, through 5 years.

    Secondary Outcome Measures

    Measure:Event free survival
    Time Frame:Measured from randomization up to 5 years
    Safety Issue:
    Description: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.

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Chimerix

    Trial Keywords

    • AML

    Last Updated

    May 4, 2021