Acute Myeloid Leukemia, Myeloid Sarcoma
Conditions
Keywords
Secondary AML, AML with Extramedullary Involvement, Myeloid Sarcoma
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.
Interventions
DRUGVAM_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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Complete Remission Rate | After completing two cycles (each cycle is 28 days) of VAM therapy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed