NCT05020665

Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML

A Phase 3, Randomized, Double-blind, Placebo-controlled 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Kronos Bio · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).

Detailed description

This is a multi-center, international, double-blind, placebo-controlled study in previously untreated participants with acute myeloid leukemia (AML) harboring nucleophosmin-1 (NPM1) mutations. Upon fulfillment of all eligibility criteria, participants were randomized 1:1 to receive intensive chemotherapy in combination with either the spleen tyrosine kinase (SYK) inhibitor entospletinib (ENTO), or placebo. The study consisted of Screening, Induction, Consolidation, End-of-Treatment, and Long-term Follow-up phases.

Conditions

• Nucleophosmin 1-mutated Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Entospletinib	400 mg, Orally as tablets
DRUG	Placebo	Orally as tablets
DRUG	Cytarabine	Continuous infusion
DRUG	Anthracycline	Either daunorubicin or idarubicin was administered via slow intravenous (IV) push

Timeline

• Start date: 2021-11-24
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2021-08-25
• Last updated: 2024-01-10
• Results posted: 2024-01-10

Locations

83 sites across 12 countries: United States, Brazil, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study