This study aims to explore a superior first-line induction remission regimen by incorporating Chidamide into the modified VAH chemotherapy combined with targeted therapy regimen, leveraging its dual epigenetic modulation mechanism.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Induction (Chi+VAH Regimen): Cycle 1: Chi+VAH regimen (28-day cycle). Assessment \& Cycle 2: CR/CRi: Repeat one cycle → Proceed to post-remission therapy. PR: Repeat one cycle → Re-assess. If CR/CRi → Proceed to post-remission therapy. NR: Discontinue study. Post-Remission / Consolidation: 1-2 cycles of either intermediate-dose Cytarabine (± targeted therapy) OR the Chi+VAH regimen. Eligible patients should proceed to allogeneic HSCT. Maintenance (Non-transplant): MRD-negative: VA (Venetoclax + Azacitidine) until relapse, intolerance, or 1 year. MRD-positive: Chi+VAH or clinical trial until MRD negativity, then switch to VA maintenance.
Composite Complete Remission Rate (CR+CRi)
Time frame: the First Induction Cycle (28days)
MRD negativity rate after the first induction cycle
Time frame: 28 days
Composite CR/CRi rate after the second induction cycle
Time frame: 56 days
2-year overall survival (OS) rate
Time frame: 2 years
2-year relapse-free survival (RFS) rate
Time frame: 2 years
Bridging Rate to Allo-HSCT
Time frame: 2 years
Non-relapse mortality (NRM)
Time frame: 2 years
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