This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy. The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
BCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-14.
Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction.
Liposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle.
Antimetabolite. Consolidation: 2 g/m² (age \<60) or 1 g/m² (age ≥60) q12h IV on days 1-3 for 3 cycles.
Recommended for high-risk or MRD+ patients after response.
Blood diseases hospital
Tianjin, Tianjin Municipality, China
RECRUITINGcomplete remission rate after induction
Time frame: up to 84 days
Event-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 5 years
Relapse-free survival
Time frame: Up to 5 years
MRD negativity rate by flow cytometry after 1 induction cycle
Time frame: At the end of the first and second induction cycles
MRD negativity rate by flow cytometry after 2 induction cycles
Time frame: At the end of the first and second induction cycles
30-day mortality
Time frame: up to 30 days
60-day mortality
Time frame: up to 60 days
MRD negativity rate by NGS OR PCR after 1 induction cycle
Time frame: up to 42 days
MRD negativity rate by NGS OR PCR after 2 induction cycles
Time frame: up to 84 days
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