Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Acute Myeloid Leukemia With High Risk | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HVA | Drug | — | UNRESOLVED |
| Standard Chemotherapy | Drug | Chemotherapy | ALIAS |
| VA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- IC regiment for Fit-AML
- interventionNames
- Drug: Standard Chemotherapy
- type
- EXPERIMENTAL
- label
- HVA regiment for Fit-AML
- interventionNames
- Drug: HVA
- type
- ACTIVE_COMPARATOR
- label
- VA regiment for unfit-AML
- interventionNames
- Drug: VA
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available