Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed, de novo or secondary, previously untreated AML
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Exclusion Criteria:
- Acute promyelocytic leukemia
- Prior chemotherapy for AML
- Prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome
- CNS leukemia
Sites / Locations
- University of California, San Diego, Moores Cancer Center
- Colorado Blood Cancer Institute
- George Washington University
- Franciscan St. Francis Health
- June E. Nylen Cancer Center
- Norton Cancer Institute
- Tulane University/Tulane Cancer Center
- Karmanos Cancer Institute
- Allina Health - Virginia Piper Cancer Institute
- Washington University School of Medicine in St. Louis
- New Mexico Cancer Care Alliance
- Montefiore Medical Center
- Northwell Health, Monter Cancer Center
- University of Cincinnati
- Oregon Health & Science University Knight Cancer Institute
- Rhode Island Hospital
- Medical University of South Carolina
- Avera Cancer Institute
- Tennessee Oncology/Sarah Cannon Research Institute
- Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center
- Methodist Healthcare System of San Antonio
- Huntsman Cancer Institute
- LDS Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control (idarubicin+cytarabine)
Dociparstat 0.125 mg/kg
Dociparstat 0.25 mg/kg
Induction: Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3) Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7) Re-induction: Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2) Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5) Consolidation: • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
Induction: Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7) Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3) Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7) Re-induction: Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5) Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2) Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5) Consolidation: Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours) Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)
Induction: Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7) Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3) Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7) Re-induction: Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5) Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2) Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5) Consolidation: Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours) Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)