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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAVEN_GROUP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Complete Remission Rate | After completing two cycles (each cycle is 28 days) of VAM therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D023981 | Sarcoma, Myeloid |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| 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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |