Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)
Inclusion Criteria
Patient eligibility criteria in accordance to the summary of Product Characteristics:
- Patients with confirmed diagnosis of acute myeloid leukemia according to the World
Health Organization (WHO) classification (including de novo AML, t-AML and s-AML) in
first complete remission (defined as less than 5% blasts in a normocellular bone
marrow assessed prior to the treatment start)
- AMLSG BiO participation incl. favourable opinion
- Presence of NPM1 mutation, CBFB-MYH11 or MLL-AF9 fusion genes as assessed in one of
the central AMLSG reference laboratories.
- Measurable MRD values (non-negative values after consolidation therapy or increase in
values over the threshold during follow-up in complete remission)
- The patient must be informed of the observation and written informed consent
regarding data privacy obtained.
- Consent for registration, storage and processing of the individual
disease-characteristics and course as well as information of the family physician and
all other treating physicians about observation participation
- No continuing systemic treatment with clonidine, steroids, and/or H2 receptor
blocking agents.