Study setting and randomization
Leukemia
RECRUITMENT, LEUKEMIA
In Germany, patients with r/r-AML are usually referred to academic hospitals. Patients under treatment in the participating centers will be asked to participate in the study. Recruitment will take place in up to 20 academic centers registered in the Study Alliance Leukemia (SAL) group (Patients have to provide written informed consent and must meet all inclusion criteria before any protocol-specific procedures are performed.Each patient must be registered in the electronic case report form (eCRF). During registration, a unique patient ID (PAT-ID) is assigned. Following registration, all eligible patients are upfront 1:1 randomized. The randomization step is triggered by the study sites using a centralized web-based tool (randomizer.at) configured by the responsible data management team. Randomization is performed stratified according to previous treatment with midostaurin. Forty patients are allocated to each arm. Twenty or more centers are selected to recruit the intended number of patients. The treatment arms are (a) the MRD-triggered arm and (b) the prophylactic arm.