Acute myeloid leukemia
Conditions
Brief summary
Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first
Detailed description
Overall survival, defined as time from randomization to the date of death from any cause, Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort, Change in Hematologic Malignancy–Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment., Proportion of patients experiencing adverse events
Interventions
Sponsors
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, defined as time from randomization to the date of death from any cause, Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort, Change in Hematologic Malignancy–Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment., Proportion of patients experiencing adverse events | — |
Countries
Czechia, Germany, Italy, Lithuania, Portugal, Romania, Spain
Outcome results
None listed