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

NCT02873338

Description:

The purpose of this study is to determine whether CX-01 when given together with standard induction and consolidation therapy for acute myeloid leukemia (AML) will increase the effectiveness of the induction/consolidation therapy. Two different doses of CX-01 will be studied and safety and tolerability will be assessed.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Randomized Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia
  • Official Title: A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: CNTX-CX-01-2015-AML-1
  • NCT ID: NCT02873338

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
CX-012-O, 3-O desulfated heparin, ODSH, PGX-100Idarubicin+Cytarabine+lower dose CX-01
IdarubicinIdamycinIdarubicin + Cytarabine
CytarabineIdarubicin + Cytarabine

Purpose

The purpose of this study is to determine whether CX-01 when given together with standard induction and consolidation therapy for acute myeloid leukemia (AML) will increase the effectiveness of the induction/consolidation therapy. Two different doses of CX-01 will be studied and safety and tolerability will be assessed.

Detailed Description

      This randomized open-label study is designed to evaluate whether the addition of either or
      both different dose levels of CX-01 to standard induction therapy and consolidation therapy
      has a beneficial effect in newly diagnosed AML patients (60 years of age or older) when
      compared to patients receiving standard induction and consolidation chemotherapy alone. 75
      patients will be randomized to one of 3 treatment groups to receive standard
      induction/consolidation therapy alone or standard induction/consolidation therapy with CX-01
      at one of 2 different dose levels (lower and higher). Patients will receive up to 2 induction
      cycles and up to 2 consolidation cycles and will participate in the study for up to 18
      months. Clinical laboratory tests will be conducted routinely, and bone marrow aspirates and
      biopsies will be performed during the induction cycles. Safety will be monitored through
      adverse events and clinical laboratory results.
    

Trial Arms

NameTypeDescriptionInterventions
Idarubicin + CytarabineActive ComparatorInduction: Idarubicin - 12 mg/m2/day slow IV injection for 3 days; Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 7 days Re-induction - same as above or: Idarubicin - 12 mg/m2/day slow IV injection for 2 days; Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 5 days Consolidation: Cytarabine - 1.0 g/m2 IV infusion over 3 hours, q12h every other day for 3 days
  • Idarubicin
  • Cytarabine
Idarubicin+Cytarabine+lower dose CX-01ExperimentalInduction: Idarubicin - 12 mg/m2/day slow IV injection for 3 days; Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 7 days; CX-01 - 4 mg/kg IV bolus followed by CX-01 0.125 mg/kg/hr as a continuous 24-hour IV infusion for 7 days Re-induction - same as above or: Idarubicin - 12 mg/m2/day slow IV injection for 2 days; Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 5 days CX-01 - 4 mg/kg IV bolus followed by CX-01 0.125 mg/kg/hr as a continuous 24-hour IV infusion for 5 days Consolidation: Cytarabine - 1.0 g/m2 IV infusion over 3 hours, q12h every other day for 3 days CX-01 - 4 mg/kg IV bolus followed by CX-01 0.125 mg/kg/hr as a continuous 24-hour IV infusion for 5 days
  • CX-01
  • Idarubicin
  • Cytarabine
Idarubicin+Cytarabine+higher dose CX-01ExperimentalInduction: Idarubicin: 12 mg/m2/day slow IV injection for 3 days; Cytarabine: 100 mg/m2/day continuous 24-hour IV infusion for 7 days; CX-01: 4 mg/kg IV bolus followed by CX-01 0.25 mg/kg/hr as a continuous 24-hour IV infusion for 7 days Re-Induction - same as above or: Idarubicin - 12 mg/m2/day slow IV injection for 2 days; Cytarabine - 100 mg/m2/day continuous 24-hour IV infusion for 5 days; CX-01 - 4 mg/kg IV bolus followed by CX-01 0.25 mg/kg/hr as a continuous 24-hour IV infusion for 5 days Consolidation: Cytarabine - 1.0 g/m2 IV infusion over 3 hours, q12h every other day for 3 days CX-01 - 4 mg/kg IV bolus followed by CX-01 0.25 mg/kg/hr as a continuous 24-hour IV infusion for 5 days
  • CX-01
  • Idarubicin
  • Cytarabine

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:60 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Morphologic complete remission evaluated by IWG criteria (ANC >1000/microliter; platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, no evidence of extramedullary disease
Time Frame:during induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Event-free survival (length of time from randomization through treatment failure)
Time Frame:every 3 months continuing until death or until 18 months after the last patient is randomized (whichever comes first)
Safety Issue:
Description:Treatment failure: failure to achieve composite complete morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response or death from any cause, whichever occurs first)
Measure:Leukemia-free survival (length of time from the date of randomization until disease relapse or patient death from any cause, whichever comes first, in patients who achieve complete remission only)
Time Frame:every 3 months continuing until death or until 18 months after the last patient is randomized (whichever comes first)
Safety Issue:
Description:
Measure:Overall survival (length of time from the date of randomization until death from any cause)
Time Frame:every 3 months continuing until death or until 18 months after the last patient is randomized (whichever comes first)
Safety Issue:
Description:
Measure:Composite complete remission rate (complete remission + complete remission with incomplete blood count recovery)
Time Frame:during induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)
Safety Issue:
Description:Complete remission: ANC >1000/microliter, platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, no evidence of extramedullary disease Complete remission with incomplete blood count recovery: ANC <1000/microliter and/or platelet count <100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, no evidence of extramedullary disease
Measure:Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse)
Time Frame:every 3 months continuing until death or until 18 months after the last patient is randomized (whichever comes first)
Safety Issue:
Description:Relapse: reappearance of leukemia blasts in the peripheral blood; or >5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease and the bone marrow blast percentage is >5% but < or equal to 20%, than a repeat bone marrow performed at least 7 days after the first marrow examination and documenting bone marrow blast percentage is >5% is necessary to establish relapse
Measure:Neutrophil recovery - Time from date of randomization to ANC recovery (ANC > 1000/microliter)
Time Frame:up to 60 days after the start of each treatment cycle
Safety Issue:
Description:
Measure:Platelet recovery - Time from date of randomization to platelet recovery (platelet count >100,000/microliter)
Time Frame:up to 60 days after the start of each treatment cycle
Safety Issue:
Description:
Measure:30-day mortality (rate of death)
Time Frame:30 days from the first day of induction treatment
Safety Issue:
Description:
Measure:60-day mortality (rate of death)
Time Frame:60 days from the first day of induction treatment
Safety Issue:
Description:
Measure:90-day mortality (rate of death)
Time Frame:90 days from the first day of induction treatment
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cantex Pharmaceuticals

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