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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with newly diagnosed high-risk Acute Myeloid Leukemia (AML), a type of blood cancer. The researchers want to see if a combination of homohartonine, venetoclax, and azacitidine (referred to as HVA) is safer and more effective than traditional intensive chemotherapy or another combination of venetoclax and azacitidine (known as VA). The goal is to find a better way to help patients who are at high risk for their leukemia.

To participate in this trial, patients must be at least 18 years old and diagnosed with high-risk AML according to specific medical guidelines. They should not have received any treatment for AML before joining the study, except for certain medications to manage symptoms. Participants can expect close monitoring throughout the trial, and they'll need to provide informed consent, meaning they'll understand the study and agree to take part. It's important to note that certain health conditions or treatments may make someone ineligible for this study, so potential participants should discuss their situation with their doctor.

Gender

ALL

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.