Finding studies
Finding studies
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Lead
Sumitomo Pharma America, Inc.
Primary Objective: • To determine the safety and tolerability including the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML Secondary Objectives: * To observe patients for any evidence of antileukemic activity of alvocidib plus 7+3 using the 2017 ELN response criteria * To establish the Recommended Phase 2 Dose (RP2D) for future studies with alvocidib in combination with 7+3 Exploratory Objective: • To assess levels of minimal residual disease (MRD) using standardized techniques (ie, multiparametric flow cytometry \[MPFC\] and next generation sequencing \[NGS\] and evaluate other potential biomarkers including, but not limited to, MCL-1 dependency.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
