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

NCT07028086 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MAVEN_01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Myeloid Sarcoma

Keywords

Secondary AML; AML with Extramedullary Involvement; Myeloid Sarcoma

Outcome Measures

Primary Outcomes (1)

• Composite Complete Remission Rate

  After completing two cycles (each cycle is 28 days) of VAM therapy

Secondary Outcomes (3)

• 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

Study Arms (1)

MAVEN_GROUP

EXPERIMENTAL

Drug: VAM_GROUP

Interventions

VAM_GROUP DRUG

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.

MAVEN_GROUP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Assessed as unfit- or frail-AML;
• Patients with a history or concurrent diagnosis of other malignancies requiring treatment
• 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
• Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
• Patients with a history of severe neurological or psychiatric disorders
• Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
• Cerebrovascular events (including transient ischemic attacks), etc.
• 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
• Patients unable to take oral medications or with malabsorption syndrome
• Patients deemed by the investigator to be unsuitable for participation in the study

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Sarcoma, Myeloid

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Sarcoma; Neoplasms, Connective and Soft Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 19, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)