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
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Dociparastat sodium Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||570 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
0.9% Normal Saline
- 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.
- 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.
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
|Contact: Marion Morrison, MDemail@example.com|
|Contact: Elizabeth Yarberfirstname.lastname@example.org|
|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|