Actively Recruiting
VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma
Led by Ruijin Hospital · Updated on 2025-07-09
48
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years
- Patients who understand the study, voluntarily participate, and sign informed consent
- Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), including secondary AML, therapy-related AML, AML with extramedullary/myeloid sarcoma, or fit AML patients aged 60 years or older
- Normal cardiac function with left ventricular ejection fraction (LVEF) of 50% or greater
- Liver and kidney function within specified limits: ALT and AST no more than 2.5 times the upper limit of normal (5 times if liver involved); total bilirubin no more than 1.5 times ULN; serum creatinine no more than 1.5 times ULN
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2
You will not qualify if you...
- Patients assessed as unfit or frail for AML treatment
- History or current diagnosis of other cancers requiring treatment
- Uncontrolled systemic diseases such as advanced infections or uncontrolled hypertension
- Known hypersensitivity to study drugs or their components
- Pregnant or breastfeeding women or those refusing contraception during the study
- History of severe neurological or psychiatric disorders
- Severe medical conditions including myocardial infarction, unstable angina, or severe arrhythmias
- Cerebrovascular events including transient ischemic attacks
- Known HIV infection or active hepatitis B or C infection; inactive hepatitis carriers or low viral titers after allowed antiviral therapy are permitted
- Use of strong or moderate CYP3A inducers/inhibitors, strong P-gp inhibitors, or related foods within 7 days before starting treatment
- Inability to take oral medications or having malabsorption syndrome
- Investigator's judgment deeming the patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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