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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide , Venetoclax, Azacitidine, Homoharringtonine | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide (Chi)+VAH | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Complete Remission Rate (CR+CRi) | the First Induction Cycle (28days) |
| Measure | Description | Time Frame |
|---|---|---|
| MRD negativity rate after the first induction cycle | 28 days | |
| Composite CR/CRi rate after the second induction cycle | 56 days | |
| 2-year overall survival (OS) rate |
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Inclusion Criteria:
Exclusion Criteria:
Patients stratified as favorable-risk AML defined by NCCN Guidelines 2022, including cytogenetic aberrations: t(8;21)(q22;q22.1); RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11.
Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration.
Cardiac function exceeding NYHA functional class II.
Confirmed human immunodeficiency virus (HIV) infection or other uncontrolled clinically significant comorbidities, including but not limited to:
6. Patients unable to receive oral chidamide and/or venetoclax administration. 7. Known hypersensitivity to any investigational product. 8. Pregnant or breastfeeding female subjects. 9. Inability to understand or adhere to the study protocol requirements. 10.Subjects deemed unsuitable for enrollment at the investigator's discretion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhangkun Li | Contact | 0769-28637333 | lzk8239@163.com |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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|
| 2 years |
| 2-year relapse-free survival (RFS) rate | 2 years |
| Bridging Rate to Allo-HSCT | 2 years |
| Non-relapse mortality (NRM) | 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |