Number of days from the first day of a chemotherapy cycle to first day platelets ≥50 x 10^9/L The time to neutrophil recovery will be assessed for the following criteria: number of days from start of treatment to the first day neutrophils ≥0.5 x 10^9/L, Number of days from start of treatment to the first day neutrophils ≥1.0 x 10^9/L
Number of days from the first day of a chemotherapy cycle to first day neutrophils ≥0.5 x 10^9/LĪt maximum 93 days from induction therapy start Assessment will be based on the IWG criteria for AML as per investigator assessment Patient who did not relapse nor die will be censored at the last adequate response assessment. The time to MRD negative status is defined as the time from randomization to first occurrence of MRD negativityįrom date of CR or CRi with adequate blood count recovery up to 5 years of follow-upĭFS is defined as the time from CR or CRi with adequate blood count recovery to relapse or death due to any cause. Percentage of patients with Minimal Residual Disease (MRD) negative statusīetween start and three months after end of treatmentĬomparisons of the MRD levels between the end of the consolidation phase during the post-consolidation phase. Patients will then be contacted by telephone every 3 months +/- 2 weeks or have a visit to follow up on their survival statusĬomplete Remission (CR) with adequate blood count recovery rateĪssessment will be based on the IWG criteria for AML as per investigator assessment Patients will enter the survival follow-up phase once they complete the safety follow up period (30 days after the last dose of midostaurin/ placebo) in case of induction failure or have relapse during post- treatment follow-up. OS is defined as the time from randomization to date of death due to any cause.
Between randomization to date of death up to 5 years of follow-up of last patients
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