This was an exploratory Phase 2, open label, randomized, multicenter , parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, 7+3) and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.~Approximately 75 subjects were to be randomized in a 1:1:1 ratio to 1 of the following treatment groups:~Group 1: cytarabine+idarubicin~Group 2: cytarabine+idarubicin + dociparstat 0.125 mg/kg/h~Group 3: cytarabine+idarubicin + dociparstat 0.25 mg/kg/h~Subjects received up to 2 induction cycles and up to 2 consolidation cycles and participated in the study for up to 18 months. Clinical laboratory tests were conducted routinely, and bone marrow aspirates and biopsies were performed during the induction cycles. Safety was monitored through adverse events and clinical laboratory results.
This was an exploratory Phase 2, open label, randomized, multicenter , parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, 7+3) and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.