RecruitingPhase 2NCT07028086

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

Sponsor

Ruijin Hospital

Enrollment

48 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myeloid Sarcoma

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug combination called VAM (venetoclax, azacitidine, and mitoxantrone) in people with specific hard-to-treat types of acute myeloid leukemia (AML), including treatment-related AML and AML that has spread outside the bone marrow. **You may be eligible if:** - You are between 18 and 65 years old - You have been newly diagnosed with secondary AML, therapy-related AML, or AML with disease outside the bone marrow - You have not received prior treatment for this AML - Your heart, liver, and kidney function are within acceptable limits - You are in reasonably good physical health **You may NOT be eligible if:** - You have the acute promyelocytic leukemia (APL) subtype - You have a serious active infection - You are pregnant or breastfeeding - You have significant heart disease or poor heart function - You have severe liver or kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

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NCT07028086

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