hva vs ia/da or va in the treatment of nd hr-aml

Conditions: Newly Diagnosed Acute Myeloid Leukemia With High Risk

Summary: the aim of this study is to evaluate the safety and efficacy of homohartonine combined with venetoclax and azacitidine (hva) versus intensive chemotherapy (ia/da) or venetoclax combined with azacitidine (va) in newly diagnosed high-risk aml patients.

the hva regimen exerts a synergistic pro-apoptotic effect and has demonstrated significant clinical efficacy against r/r aml and also overcomes adaptive resistance observed in the va regimen. exploratory work with small sample sizes in first-line settings suggests that combination of hht and ven+aza exhibits potent anti-aml effects with good safety profiles, particularly in overcoming the impact of high-risk factors associated with aml relative to standard treatments. this indicates its potential as a more ideal option for the treatment of newly diagnosed aml with high risk factors. therefore a prospective, multi-center, randomized controlled clinical study is planned to evaluate the efficacy and safety of the hva regimen compared to intensive chemotherapy (ia/da) or venetoclax plus azacitidine (va) regimens in newly diagnosed high-risk fit-aml or unfit aml patients.

Eligibility criteria:
inclusion criteria: * according to the world health organization (who) classification of newly diagnosed with aml patients; * age ≥18 years old; * high-risk patients should meet any of the following criteria: ① high risk group according to the european leukemia risk stratification (eln) 2022; (2) secondary aml (saml) which develops from myelodysplastic syndrome (mds), bone marrow hyperplastic tumor (mpn) or chronic myeloid cell leukemia, et.; (3) treatment-related aml (t-aml), patients have a history of cytotoxic treatment record or ionizing radiation therapy. * patients did not receive anti-aml therapy (except leukopenia therapy, such as hydroxyurea or cytarabine \< 1.0g/d) after the diagnosis of aml; * expected survival ≥12 weeks; * the eastern tumor cooperation group (ecog) score 3 points or less; * kidney function: creatinine clearance acuity 30 ml/min; * liver function: alt \< 5 times normal value, bilirubin \< 3 times normal value; * sign the informed consent form and understand and abide by the plan calls for process. exclusion criteria: * acute promyelocytic leukemia; * with central nervous system leukemia (cnsl) ; * the cardiac function \> level 2; * the aids virus (hiv) infection; * other clinical significance of uncontrolled condition, including but not limited to: (1) out of control, or active systemic infection (viruses, bacteria or fungi); (2) chronic hepatitis b virus (hbv) or hepatitis c virus (hcv) requiring treatment; (3) need to actively deal with the merger of the second tumor; * can't take oral treatment or having a gastrointestinal disease impact ing the absorption; * being allergy to the experimental drugs; * pregnant and lactating women; * patients who could not understand or adhere to the study protocol; * patients deemed by the investigator to be ineligible for enrollment.

Keywords: hva regimen intensive chenmotherapy fit randomized controlled trial phase 3 ven combined with aza unfit newly diagnosed high risk acute myeloid leukemia