NCT07643636Not yet recruitingPhase 2
A Single-arm, Single-center Clinical Trial Evaluating the Efficacy and Safety of a Regimen Combining Chidamide With Venetoclax, Azacitidine, and Homoharringtonine in the Treatment of Intermediate- to High-risk Fit AML Patients
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dongguan People's Hospital
- Enrollment
- 46
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria.
- •Age ranging from 18 to 60 years, no restriction on gender.
- •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.
- •Estimated overall survival ≥12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points.
- •Renal function: calculated creatinine clearance (CrCl) ≥30 mL/min.
- •Hepatic function: alanine aminotransferase (ALT) <5× upper limit of normal (ULN); total bilirubin <3× ULN.
- •Able to provide written informed consent and understand as well as comply with all study-specified procedures.
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-MYH
- •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:
- •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.
- •Known hypersensitivity to any investigational product.
- •Pregnant or breastfeeding female subjects.
- •Inability to understand or adhere to the study protocol requirements. 10.Subjects deemed unsuitable for enrollment at the investigator's discretion
Arms & Interventions
Chidamide , Venetoclax, Azacitidine, Homoharringtonine
Experimental
Intervention: Chidamide (Chi)+VAH (Drug)
Investigators
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