A Pilot Study of Dociparstat Sodium (ODSH) in Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open-label pilot study that evaluated the safety and preliminary evidence of a
      therapeutic effect of dociparstat in conjunction with standard induction and consolidation
      therapy for acute myeloid leukemia (AML).
    

Detailed description: 
      The primary objectives of this study were the following:

        1. To evaluate the safety and tolerability of dociparstat in patients with acute myeloid
           leukemia (AML) receiving cytarabine and idarubicin induction or cytarabine consolidation
           chemotherapy.

        2. To determine whether there is preliminary evidence of an effect of dociparstat on time
           to transfusion-independent platelet recovery in AML patients receiving cytarabine and
           idarubicin induction or cytarabine consolidation chemotherapy.

      The secondary objectives of this study were the following:

        1. To determine whether there is preliminary evidence of an effect of dociparstat on
           remission rate following cytarabine and idarubicin induction in AML patients.

        2. To determine whether there is preliminary evidence of an effect of dociparstat on
           improving platelet nadir counts in AML patients receiving cytarabine and idarubicin
           induction or cytarabine consolidation chemotherapy.

        3. To determine whether there is preliminary evidence of an effect of dociparstat on
           decreasing the number of platelet transfusions in AML patients receiving cytarabine and
           idarubicin induction or cytarabine consolidation chemotherapy.

        4. To determine whether there is preliminary evidence of an effect of dociparstat on
           reducing overall side effects of chemotherapy in AML patients receiving cytarabine and
           idarubicin induction or cytarabine consolidation chemotherapy.

      This study enrolled patients with newly diagnosed, previously untreated AML; subjects with
      acute promyelocytic leukemia and acute megakaryoblastic leukemia subtypes were excluded.

      All patients were to receive standard induction chemotherapy with cytarabine 100 mg/m2/day by
      continuous intravenous (IV) infusion over 24 hours daily for 7 days (Days 1-7) plus
      idarubicin 12 mg/m2/day by IV injection daily for 3 days (Days 1-3). For consolidation,
      patients younger than 60 were to receive cytarabine at a dose of 3 grams/m2 over 3 hours,
      every 12 hours on days 1, 3, and 5.

      Induction cycle: dociparstat 4 mg/kg IV bolus Day 1, 30 minutes after completion of
      administration of the first dose of idarubicin, then dociparstat 0.25 mg/kg/hour for 24 hours
      daily by continuous IV infusion Days 1-7.

      Consolidation cycle: dociparstat mg/kg IV bolus Day 1 administered 30 minutes after
      completion of infusion of the first dose of cytarabine then dociparstat 0.25 mg/kg/hour for
      24 hours daily by continuous IV infusion Days 1-5

      In total, there were 7 days in the induction cycle and 5 days in the consolidation cycles.
    

Intervention name(s): Dociparstat sodium
Intervention type(s): Drug
Intervention description(s): The following induction regimen was administered:
Cytarabine (100 mg/m2/day) via continuous intravenous (IV) infusion 24 hours daily for 7 days.
Idarubicin (12 mg/m2/day) IV on Days 1, 2, and 3.
Dociparstat (4 mg/kg) given over 5 minutes IV, immediately after the idarubicin dose on Day 1, followed by a continuous IV infusion (0.25 mg/kg/hr for 24 hours daily) for a total of 7 days.
Other intervention name(s): dociparstat; ODSH; CX-01; 2-O, 3-O desulfated heparin
Intervention MeSH terms: Heparin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myeloid Leukemia; AML; ODSH; ODSH-AML; CX-01; dociparstat; dociparstat sodium; 2-O, 3-O desulfated heparin