NCT07028086

VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma

Prospective, Multicenter, Single-Arm Clinical Study of Mitoxantrone Liposome Combined With Azacitidine and Venetoclax in the Treatment of Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The mitoxantrone liposomal enhances the tissue permeability of mitoxantrone by incorporating liposomal groups compared to the conventional mitoxantrone formulation, while also reducing the concentration of free mitoxantrone, thereby minimizing drug side effects-particularly cardiotoxicity. Building upon this, the investigators aim to investigate the efficacy and safety of the liposomal mitoxantrone hydrochloride injection in patients with secondary AML, AML with extramedullary involvement, or myeloid sarcoma, in order to explore alternative therapeutic strategies for these populations.

Conditions

• Acute Myeloid Leukemia
• Myeloid Sarcoma

Interventions

Type	Name	Description
DRUG	VAM_GROUP	Mitoxantrone Liposome 24mg/m², IV, administered as a single dose or divided doses at the investigator's discretion based on the patient's condition; Azacitidine 75mg/m², IV drip, Day 1 to Day 7; Venetoclax 100mg on Day 1, 200mg on Day 2, and 400mg on Day 3 to Day 14.

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-06-01
• Completion: 2028-04-01
• First posted: 2025-06-19
• Last updated: 2025-07-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study