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RecruitingPhase 3NCT06810791

HVA vs IA/DA or VA in the Treatment of ND HR-AML

The Efficacy and Safety of Homoharringtonine Combined With Venetoclax and Azacitidine Versus Standard Chemotherapy or VA in the Treatment of Acute Myeloid Leukemia With High-risk, a Multicenter, Prospective, Randomized Study

Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

876 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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 Criteria10

  • 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.

Interventions

DRUGHVA

Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7.

DRUGVA

VEN is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 28, and AZA (75 mg/m2) is given subcutaneously from day 1 to 7.

DRUGStandard Chemotherapy

Standard Chemotherapy includes IA(Idarubicin combined with Cytarabine) or DA(Daunorubicin combined with Cytarabine). IDA is given by venous drip daily at 12mg/m2, or DNR is given by venous drip daily at 60mg/m2, from day 1-3, combined with Ara-C at 100mg/m2 by continuously venous drip from day 1-7.

Locations(1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT06810791