Multi-center, randomized open-label study to evaluate the safety and efficacy of immunotherapy with subcutaneous Maxamine (histamine dihydrochloride) plus Proleukin (interleukin-2) versus no treatment (standard of care) in patients with acute myeloid leukemia in first or subsequent complete remission (CR).

Trial Profile

Multi-center, randomized open-label study to evaluate the safety and efficacy of immunotherapy with subcutaneous Maxamine (histamine dihydrochloride) plus Proleukin (interleukin-2) versus no treatment (standard of care) in patients with acute myeloid leukemia in first or subsequent complete remission (CR).

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2013

At a glance

  • Drugs Histamine dihydrochloride (Primary) ; Aldesleukin
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Maxim Pharmaceuticals
  • Most Recent Events

    • 23 Aug 2010 Epicept Corporation received a refusal to file letter from the US FDA on the Ceplene NDA, which was based on data from this study and supporting evidence.
    • 04 Jun 2009 Six-year follow-up results have been presented at the 14th Congress of the European Hematology Association.
    • 04 Jun 2009 Six-year outcome data were presented at the European Hematology Associations 14th Congress, according to a EpiCept media release.
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