VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid 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
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
Treatments tested in this trial
- VAM_GROUP
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov