Phase 3 AGILITY Study

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

COMPOUND

Entospletinib (oral SYK inhibitor)

TRIAL STATUS

Actively recruiting

TRIAL INFORMATION

The Phase 3 AGILITY trial is enrolling patients newly diagnosed with NPM1-mutated acute myeloid leukemia, who are considered fit for intensive induction chemotherapy.

The trial is investigating whether the addition of Kronos Bio’s investigational compound, entospletinib, to standard of care chemotherapy will improve the rate of complete response without evidence of measurable residual disease (MRD-negative CR) and improve the duration of event-free survival.

We have sites open in the United States, Canada, Europe and Asia.  For a list of sites, click here.

TRIAL DESIGN

ABOUT NPM1

NPM1 (nucleophosmin 1) is one of the most commonly mutated genes in AML, present in about 30% of cases. At the time of diagnosis, patients with AML are routinely screened for NPM1 mutation. 

ABOUT PRIMARY ENDPOINT

Measurable residual disease-negative complete response, after two cycles of chemotherapy

Measurable residual disease (MRD) is a term that describes small numbers of leukemic cells that are still detectable during or after treatment, even when a patient has achieved complete response by standard criteria. Remaining leukemic cells in the body can become active and start to multiply, resulting in a relapse of the disease.

ABOUT KEY SECONDARY ENDPOINT

The key secondary endpoint of the trial is event-free survival.

For more information, please contact clinicaltrials@kronosbio.com or view the study on ClinicalTrials.gov.