75
Participants
Start Date
August 31, 2016
Primary Completion Date
June 30, 2019
Study Completion Date
June 30, 2019
Dociparstat sodium
Subjects received 4 mg/kg dociparstat intravenous (IV) bolus followed by doses of 0.125 or 0.25 mg/kg/hr dociparstat given on Days 1 through 7 with standard induction therapy, on Days 1 through 5 or 7 with standard re-induction therapy, and on Days 1, 3, and 5 with standard consolidation therapy.
Idarubicin
Subjects received 12 mg/m2/day idarubicin by slow (10 to 15 minutes) intravenous (IV) injection daily on Days 1, 2 and 3 of induction therapy, and on Days 1 and 2 of re-induction therapy.
Cytarabine
Subjects received 100 mg/m2/day cytarabine by continuous intravenous (IV) infusion on Days 1 through 7 of induction therapy and on Days 1 through 5 of re-induction therapy. During consolidation therapy, subjected received 1.0 g/m2 cytarabine IV infusion given over 3 hours every 12 hours on Days 1, 3, and 5.
Montefiore Medical Center, The Bronx
Northwell Health, Monter Cancer Center, Lake Success
George Washington University, Washington D.C.
Medical University of South Carolina, Charleston
Tennessee Oncology/Sarah Cannon Research Institute, Nashville
Norton Cancer Institute, Louisville
University of Cincinnati, Cincinnati
Franciscan St. Francis Health, Indianapolis
Karmanos Cancer Institute, Detroit
June E. Nylen Cancer Center, Sioux City
Allina Health - Virginia Piper Cancer Institute, Minneapolis
Avera Cancer Institute, Sioux Falls
Washington University School of Medicine in St. Louis, St Louis
Tulane University/Tulane Cancer Center, New Orleans
Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center, Dallas
Methodist Healthcare System of San Antonio, San Antonio
Colorado Blood Cancer Institute, Denver
Huntsman Cancer Institute, Salt Lake City
LDS Hospital, Salt Lake City
New Mexico Cancer Care Alliance, Albuquerque
University of California, San Diego, Moores Cancer Center, La Jolla
Oregon Health & Science University Knight Cancer Institute, Portland
Rhode Island Hospital, Providence
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY