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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02873338.
The primary efficacy endpoint was to assess whether dociparstat in conjunction with
standard induction therapy for AML increased the complete remission rate based on the
International Working Group AML response criteria.
A total of 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/hr
- Group 3: cytarabine + idarubicin + dociparstat 0.25 mg/kg/hr
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.
Lead OrganizationChimerix
