NCT06810791 HVA vs IA/DA or VA in the Treatment of ND HR-AML
| NCT ID | NCT06810791 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Newly Diagnosed Acute Myeloid Leukemia With High Risk |
| Study Type | INTERVENTIONAL |
| Enrollment | 876 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 876 participants in total. It began in 2025-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Guopan Yu
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06810791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Newly Diagnosed Acute Myeloid Leukemia With High Risk. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06810791 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 876 participants.
Is NCT06810791 currently recruiting?
Yes, NCT06810791 is actively recruiting participants. Contact the research team at yugpp@163.com for enrollment information.
Where is the NCT06810791 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06810791 clinical trial?
NCT06810791 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Guopan Yu at Nanfang Hospital, Southern Medical University. The trial plans to enroll 876 participants.
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