Acute Myeloid Leukemia
Conditions
Interventions
HHT+AZA+VEN Treatment Group:HHT: 1.0 mg/m^2 IV on days 1-7
Venetoclax: 200 mg on day 1, 400 mg on day 2, 100 mg IV on days 3-14
Azacitidine: 75 mg/m^2 SC on days 1-7. One cycle every 28 days, up to 2 cycles. Sorafenib or Gilteritinib added for FLT3-positive patients.
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Previously untreated patients with acute myeloid leukemia (AML), aged 18–60 years inclusive. 2. Eastern Cooperative Oncology Group (ECOG) performance status score 0–2. 3. Confirmed diagnosis of acute myeloid leukemia (excluding acute promyelocytic leukemia) based on hematology analysis, bone marrow morphology, immunophenotyping, conventional cytogenetic analysis, and gene mutation testing. 4. No prior treatment with homoharringtonine, venetoclax, or hypomethylating agents. 5. No history of prior malignant disease except myelodysplastic syndrome (MDS); no concurrent other malignancies. 6. Expected overall survival of more than 12 weeks. 7. Provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Not eligible for intensive induction chemotherapy, defined as: Eastern Cooperative Oncology Group (ECOG) performance status score >=3; history of cardiac disease (congestive heart failure requiring treatment, ejection fraction 1.5× to <=3.0× upper limit of normal (ULN); or any other comorbidity considered by the investigator to preclude conventional intensive chemotherapy. 2. Acute promyelocytic leukemia (APL). 3. History of allergic disease or allergic constitution; hypersensitivity to homoharringtonine, venetoclax, or hypomethylating agents. 4. Patients currently enrolled in other clinical trials. 5. Any other factors deemed by the investigator to be unsuitable for enrollment or that may interfere with the subject’s ability to participate in or complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response (CR) + Complete Response with Incomplete Hematologic Recovery (CRi) rate and Molecular Response Negative (MRD-negative) rate after first treatment cycle;Severe Adverse Events Occurring During Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response (CR) + Complete Response with Incomplete Hematologic Recovery (CRi) rate and Molecular Response Negative (MRD-negative) rate after second treatment cycle;Duration of Response (DOR) within 2 years;Overall Survival (OS) at 2 years;Event-Free Survival (EFS) at 2 years; | — |
Countries
China
Contacts
Public ContactYan Xiaojing
The First Hospital of China Medical University
Outcome results
None listed