NCT07028086RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 9 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 4 Jun 2025
- Start date
- 20 Jun 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Acute myeloid leukemia, Sarcoma
- NCT number
- NCT07028086
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 20 Jun 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a history or concurrent diagnosis of other malignancies requiring treatment
- 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
Other illness
- 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
- Patients with a history of severe neurological or psychiatric disorders
- Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
- Patients unable to take oral medications or with malabsorption syndrome
Other
- Assessed as unfit- or frail-AML;
- Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
- Cerebrovascular events (including transient ischemic attacks), etc.
- Patients deemed by the investigator to be unsuitable for participation in the study
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.