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).
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History