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

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia, Myeloid Sarcoma

In brief

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.

Key facts

Study ID: NCT07028086
Run by: Ruijin Hospital
People needed: 48
Starts: 2025-06-20
Expected to finish: 2028-04-01
Last updated by the study team: 2025-07-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
Age 18-65 years
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;
Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
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
Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2

You may not qualify if…

Assessed as unfit- or frail-AML;
Patients with a history or concurrent diagnosis of other malignancies requiring treatment
Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
Patients with a history of severe neurological or psychiatric disorders
Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
Cerebrovascular events (including transient ischemic attacks), etc.
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
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
Patients unable to take oral medications or with malabsorption syndrome
Patients deemed by the investigator to be unsuitable for participation in the study

Where it is running

Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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