NCT06810791RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 876 (estimated)
- First submitted
- 16 Jan 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06810791
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 876
- From 1 Jan 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- Acute promyelocytic leukemia;
- With central nervous system leukemia (CNSL) ;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.