Randomized Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantex Pharmaceuticals; Chimerix
• Treatments: Cytarabine; Heparin; Idarubicin

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