Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571645
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : May 4, 2021
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 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 : May 1, 2024
Estimated Study Completion Date : February 15, 2026


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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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.

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


Contacts
Layout table for location contacts
Contact: Marion Morrison, MD 919.313.2977 mmorrison@chimerix.com
Contact: Elizabeth Yarber 919-886-1140 eyarber@chimerix.com

Locations
Layout table for location information
United States, Kentucky
Norton Cancer Institute, St. Matthews Campus Recruiting
Louisville, Kentucky, United States, 40207
Contact: Donald Stevens, MD         
United States, Minnesota
Allina Health System / Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Michaela Tsai, MD         
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Contact: Nashat Gabrail, MD         
United States, Utah
University of Utah / Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Paul Shami, MD         
Sponsors and Collaborators
Chimerix
Layout table for additonal information
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: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action