AML (Acute Myeloid Leukemia)
Conditions
Brief summary
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.
Interventions
DRUGChidamide (Chi)+VAH
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.
Sponsors
Dongguan People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria. 2. Age ranging from 18 to 60 years, no restriction on gender. 3. No prior anti-AML systemic therapy after AML diagnosis; cytoreductive treatment (e.g., hydroxyurea or cytarabine at a daily dose \<1.0 g) is permitted as exception. 4. Estimated overall survival ≥12 weeks. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points. 6. Renal function: calculated creatinine clearance (CrCl) ≥30 mL/min. 7. Hepatic function: alanine aminotransferase (ALT) \<5× upper limit of normal (ULN); total bilirubin \<3× ULN. 8. Able to provide written informed consent and understand as well as comply with all study-specified procedures.
Exclusion criteria
1. 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. 2. Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration. 3. Cardiac function exceeding NYHA functional class II. 4. Confirmed human immunodeficiency virus (HIV) infection or other uncontrolled clinically significant comorbidities, including but not limited to: * Uncontrolled or active systemic infection (viral, bacterial or fungal); ② Concurrent second primary malignancy requiring urgent clinical intervention. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Complete Remission Rate （CR+CRi） | the First Induction Cycle （28days） |
Secondary
| Measure | 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 | 2 years |
| 2-year relapse-free survival (RFS) rate | 2 years |
| Bridging Rate to Allo-HSCT | 2 years |
| Non-relapse mortality (NRM) | 2 years |
Contacts
CONTACTZhangkun Li
Outcome results
None listed