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.


Continue Reading

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.

Status: Recruiting

This study is sponsored by Kronos Bio.

Reference

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.