Title: A Study to Assess the Efficacy and Safety of Entospletinib in Combination with Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-Mutated Acute Myeloid Leukemia
Study Director: Director of Clinical Operations at Kronos Bio
Description: Researchers are conducting a phase 3 trial to compare entospletinib plus chemotherapy with chemotherapy alone in previously untreated patients with acute myeloid leukemia (AML) harboring NPM1 mutations.
In this randomized trial, patients will receive intensive chemotherapy — cytarabine plus daunorubicin or idarubicin — in combination with either entospletinib or placebo.
The study will consist of screening, induction, consolidation, end-of-treatment, and long-term follow-up phases.
The primary endpoint is the rate of measurable residual disease-negative complete response. Secondary endpoints include event-free survival, relapse-free survival, overall survival, complete response rate, and treatment-emergent adverse events.
To be eligible for this study, patients must have a diagnosis of previously untreated de novo AML, AML with features of myelodysplastic syndromes, or therapy-related AML. For a complete list of eligibility criteria, please refer to the reference.
This study is sponsored by Kronos Bio.
Clinicaltrials.gov. A study to assess the efficacy and safety of entospletinib in combination with intensive induction and consolidation chemotherapy in adults with newly diagnosed nucleophosmin 1-mutated acute myeloid leukemia. NCT05020665. Accessed November 15, 2021.