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

Phase 2

Recruiting

• Conditions: Acute Myeloid Leukemia; Myeloid Sarcoma
• Interventions: Drug: VAM_GROUP

• Registration Number: NCT07028086
• Lead Sponsor: Ruijin Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-19
• Study Start: 2025-06-20
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-06
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
2. Age 18-65 years
3. Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid leukemia; b. Therapy-related acute myeloid leukemia; c. AML with extramedullary/myeloid sarcoma; d. Age ≥60 years, assessed as fit-AML;
4. Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
5. Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for patients with liver involvement); total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN
6. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2

Exclusion Criteria

1. Assessed as unfit- or frail-AML;
2. Patients with a history or concurrent diagnosis of other malignancies requiring treatment
3. Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
4. Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
5. Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
6. Patients with a history of severe neurological or psychiatric disorders
7. Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
8. Cerebrovascular events (including transient ischemic attacks), etc.
9. Known infection with human immunodeficiency virus (HIV); active hepatitis B or C infection; inactive hepatitis carriers or subjects with low viral titers after receiving non-prohibited antiviral therapy are not excluded
10. Subjects who have received strong or moderate CYP3A inducers/inhibitors or strong P-gp inhibitors or related foods within 7 days before starting the study treatment
11. Patients unable to take oral medications or with malabsorption syndrome
12. Patients deemed by the investigator to be unsuitable for participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MAVEN_GROUP	VAM_GROUP	-

Primary Outcome Measures

Name	Time	Method
Composite Complete Remission Rate	After completing two cycles (each cycle is 28 days) of VAM therapy

Secondary Outcome Measures

Name	Time	Method
Event-Free Survival	from data of AML diagnosis until the data of events, assessed up to 2 years
Overall Survival	from enrollment to study completion, a maximum of 2 years
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	During the two cycles (each cycle is 28 days) of VAM therapy and follow-up for 2 years after completion

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China