This is a non-interventional multi-center study (NIS) in adult patients with AML in first complete remission with measurable minimal residual disease (MRD). Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first complete remission. Therapy is administered for 10 treatment cycles as outlined in the Summary of Product Characteristics.
Study Type
OBSERVATIONAL
Enrollment
8
Vivantes Hospital Neukölln
Berlin, Germany
Charite, University Medical School of Berlin
Berlin, Germany
Darmstadt Clinic
Darmstadt, Germany
University Hospital of Düsseldorf
Düsseldorf, Germany
Malteser Krankenhaus St. Franziskus Hospital
Flensburg, Germany
University of Freiburg
Freiburg im Breisgau, Germany
Wilhelm-Anton-Hospital gGmbH Goch
Goch, Germany
Klinikum Region Hannover GmbH, Krankenhaus Siloah
Hanover, Germany
Hannover Medical School
Hanover, Germany
Saarland University Medical Center
Homburg/Saar, Germany
...and 12 more locations
leukemia-free survival / cumulative incidence of relapse
Time frame: two years
Toxicity induced by the preemptive treatment with Ceplene and IL-2
Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization
Time frame: 18 months
Overall survival
Time frame: two years
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