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Compares treatment options for Newly Diagnosed Acute Myeloid Leukemia With High Risk
Official title HVA vs IA/DA or VA in the Treatment of ND HR-AML
ClinicalTrials.gov ID: NCT06810791
What this study is testing
What is HVA?
HVA is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for newly diagnosed acute myeloid leukemia with high risk.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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...
- Can't take oral treatment or having a gastrointestinal disease impact ing the absorption;
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.