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

Primary Purpose

Acute Myeloid Leukemia

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dociparastat sodium
Placebo
Sponsored by
Chimerix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UC Irvine Medical Center
  • University of Kansas Cancer Center
  • Norton Cancer Institute, St. Matthews Campus
  • Tulane University School of Medicine
  • Henry Ford Health System
  • Allina Health System / Virginia Piper Cancer Institute
  • New York Medical College
  • Mount Sanai School of Medicine
  • East Carolina University Vidant Medical Center
  • Gabrail Cancer Center
  • Spartanburg Medical Gibbs Cancer Center
  • Baylor
  • University of Utah / Huntsman Cancer Institute
  • University of Virginia Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dociparstat sodium (DSTAT)

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival
Overall survival is defined as time until death from any cause, through 5 years.

Secondary Outcome Measures

Event free survival
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.

Full Information

First Posted
September 25, 2020
Last Updated
June 15, 2022
Sponsor
Chimerix
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1. Study Identification

Unique Protocol Identification Number
NCT04571645
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chimerix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dociparstat sodium (DSTAT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dociparastat sodium
Other Intervention Name(s)
DSTAT, CX-01, 2-0,3-0 desulfated heparin, ODSH
Intervention Description
Dociparstat is a glycosaminoglycan derived from porcine heparin.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% Normal Saline, Normal saline, Sodium chloride 0.9%
Intervention Description
0.9% Normal Saline
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is defined as time until death from any cause, through 5 years.
Time Frame
Measured from randomization up to 5 years
Secondary Outcome Measure Information:
Title
Event free survival
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.
Time Frame
Measured from randomization up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Norton Cancer Institute, St. Matthews Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Allina Health System / Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
New York Medical College
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Mount Sanai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
East Carolina University Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Spartanburg Medical Gibbs Cancer Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Baylor
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Utah / Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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