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RECRUITING

NCT07028086

PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-20

Completion Date

2028-04

Last Updated

2025-07-09

Healthy Volunteers

Conditions

Acute Myeloid Leukemia Myeloid Sarcoma

Interventions

DRUG

VAM_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.

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

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China