Comparing HVA regimen to standard chemotherapy for high-risk acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of a new treatment regimen combining homohartonine with venetoclax and azacitidine (HVA) against standard intensive chemotherapy or a combination of venetoclax and azacitidine (VA) in patients with newly diagnosed high-risk acute myeloid leukemia (AML). The study will be conducted as a multi-center, randomized controlled trial, focusing on patients who are either fit or unfit for intensive chemotherapy. The HVA regimen is expected to provide a synergistic effect that may improve treatment outcomes compared to existing therapies. The trial will assess both the efficacy and safety of the HVA regimen in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Hematology,Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Guopan Yu — Nanfang Hospital, Southern Medical University
• Study coordinator: Guopan Yu
• Email: yugpp@163.com
• Phone: +8615876559968

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Alternating venetoclax+azacitidine and low-dose cladribine+homoharringtonine+cytarabine for unfit newly diagnosed AML

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• Investigating APL-4098 with Azacitidine for treating relapsed or refractory AML and high-risk MDS

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• Combining SKLB1028 with standard chemotherapy for newly diagnosed acute myeloid leukemia

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• Horizon Two: A multi-arm trial for high-risk newly diagnosed multiple myeloma

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• Donor γδ T cell infusion to prevent relapse after stem cell transplant in high‑risk AML

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.