FLAsH-IV-AML: A phase I/II multi-center study to assess the tolerability and efficacy of the addition of hydroxyurea to salvage treatment with fludarabine, ara-C, idarubicin and venetoclax for adults with relapsed or refractory acute myeloid leukemia

Adults (≥ 18 years of age) with relapsed or refractory acute myeloid leukemia (R/R AML)

1-year EFS defined as from the time from initiation of study treatment to the first occurrence of treatment failure, hematologic relapse from CR/CRi, or death from any cause

Safety and tolerability (frequency and severity of non-hematological toxicities, including potential ara-C or fludarabine related neurological or dermatological adverse events)., Efficacy profile; 1- and 2-year OS, 2-year EFS, 1- and 2-year RFS, 1- and 2-year cumulative incidence of hematological relapse, response rates (CR, CRi, MLFS, PR, MRD-negativity)., Time to hematopoietic recovery (ANC 0.5 and 1.0 x 109/L; platelets 50 and 100 x 109/L) after each chemotherapy treatment cycle, defined as the time from the start of the cycle until recovery, Rate of patients bridged to allo-HCT, Rate of 30 and 60 day mortality, Rate of 30 and 60 day requirement of intensive care admission

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