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

ConditionsAcute Myeloid LeukemiaMyeloid Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRuijin Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: MAVEN_GROUPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite Complete Remission Rate

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

Secondary outcomes

1

Event-Free Survival

Time frame
from data of AML diagnosis until the data of events, assessed up to 2 years
2

Overall Survival

Time frame
from enrollment to study completion, a maximum of 2 years
3

Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame
During the two cycles (each cycle is 28 days) of VAM therapy and follow-up for 2 years after completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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