NCT07511062

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML

Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated/Deleted AML Patients

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Northside Hospital, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients

Conditions

• Acute Myeloid Leukemia
• TP53 Gene Mutation

Interventions

Type	Name	Description
DRUG	Decitabine	20mg/m2/d x5 days (induction \& consolidation)
DRUG	Venetoclax	400mg/d x14 days (induction); 400mg/d x7 days (consolidation)
DRUG	Axatilimab	Dose escalation, given on Days 1 and 15 of each cycle

Timeline

• Start date: 2026-08-01
• Primary completion: 2029-08-01
• Completion: 2030-08-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study