A Phase 2 interventional study of Intervention for Venetoclax and Intervention for Homoharringtonine in Acute Myeloid Leukemia (AML), sponsored by First People's Hospital of Hangzhou. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by First People's Hospital of Hangzhou · Phase 2, Interventional, and Treatment
This study is a single-arm, prospective, multi-center exploratory clinical trial. A total of 61 patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy will be enrolled. The Simon two-stage design will be adopted to control the type I and type II errors, with the minimum acceptable composite remission rate of 65% and a power of 80%.
Prior to treatment, subjects will undergo screening within 28 days, including bone marrow aspiration, genetic testing, ECOG performance status assessment, and organ function evaluation. Data will be recorded in Excel and subject to unified quality control. During the treatment period, G-CSF (granulocyte colony-stimulating factor) will be administered subcutaneously as appropriate, and supportive care such as antiemetic and hydration therapy will be provided routinely.
For patients who achieve remission, individualized consolidation therapy will be given: those eligible for transplantation will undergo allogeneic hematopoietic stem cell transplantation; those who can tolerate moderate-intensity treatment will receive consolidation with medium-dose cytarabine first, followed by 4 cycles of VHAG regimen consolidation. Patients with FLT3 mutations will receive additional targeted therapy during consolidation.
Safety assessment will be conducted in accordance with the NCI-CTCAE Version 5.0. For grade 4 hematological toxicity or severe non-hematological toxicity, the treatment dose will be adjusted or the treatment will be suspended. Severe adverse events will be reported in a timely manner, and all research-related data will be retained for at least 10 years in accordance with relevant regulations.
According to the detailed inclusion and exclusion criteria, first-line induction therapy: VHAG regimen Venetoclax 100 mg on day 2, 200 mg on day 3, 400 mg on days 4-10; Homoharringtonine 1 mg/m² on days 1-7; Azacitidine 75 mg/m² on days 1-7; G-CSF 5 μg/kg subcutaneously starting on day 0;G-CSF to be discontinued if WBC ≥ 30 × 10⁹/L.
One cycle every 4 weeks, for a total of 2 cycles.Patients who achieve CR/CRi/MLFS/PR after the first cycle will receive one additional cycle of the same regimen for consolidation(venetoclax 400 mg on days 1-7 in the second course).
Subsequent treatment After achieving remission, re-evaluate tolerability comprehensively based on age, performance status, comorbidities, and other factors.
Patients eligible for transplantation will undergo allogeneic hematopoietic stem cell transplantation.
Transplant-ineligible patients:
Those tolerable to intensive chemotherapy may receive1-2 courses of intermediate-dose cytarabine consolidation,followed by 4 courses of VHAG consolidation.
Those intolerant to intensive chemotherapy will continue6 courses of VHAG consolidation.
Patients with FLT3 mutations in the intermediate- or high-risk groups may receive combination therapy with a FLT3 inhibitor during consolidation.
Endpoints Primary endpoint: Composite complete remission rate (CRc: CR + CRi)
Secondary endpoints:
Overall response rate (ORR: CR + CRi + MLFS + PR) Overall survival (OS) Relapse-free survival (RFS) Rate of measurable residual disease (MRD) negativity Safety Hematologic and non-hematologic toxicities (NCI CTCAE version 5.0) Exploratory biomarker evaluation
Exclusion Criteria:
All enrolled patients will receive the VHAG combination regimen, consisting of venetoclax, homoharringtonine, azacitidine, and G-CSF, according to the study protocol. The regimen includes induction therapy followed by optional consolidation cycles as specified in the protocol.
Drug: Intervention for Venetoclax · Drug: Intervention for Homoharringtonine · Drug: Intervention for Azacitidine · Drug: Intervention for G-CSF
Oral administration of venetoclax. The starting dose is 100 mg on Day 2, 200 mg on Day 3, and 400 mg once daily from Day 4 to Day 10 of each induction cycle. Dose adjustments may be made per protocol based on tolerability and safety.
Intravenous infusion of homoharringtonine at a dose of 1 mg/m² daily from Day 1 to Day 7 of each induction cycle.
Subcutaneous or intravenous administration of azacitidine at a dose of 75 mg/m² daily from Day 1 to Day 7 of each induction cycle.
Subcutaneous administration of G-CSF at a dose of 5 μg/kg daily, initiated prior to the start of induction therapy (Day 0). Discontinuation will be per protocol when the white blood cell count (WBC) exceeds 30 × 10⁹/L.
CRc（CR+CRi）
Composite complete remission (CR) plus CR with incomplete hematologic recovery
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
ORR（CR+CRi+MLFS+PR）
Objective Response Rate (Complete Response + Complete Response with incomplete hematologic recovery + Marrow Leukemia-Free State + Partial Response)
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
OS
Overall Survival
Time frame: 1year
RFS
Relapse-Free Survival
Time frame: 1year
MRD
Rate of negative conversion of evaluable minimal residual disease (MRD)
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
NCICTCAEv5.0
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
EBS
Exploratory biomarker assessment
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
Plan to share: No — The individual participant data (IPD) will not be shared, due to the constraints of patient privacy protection, informed consent limitations, and institutional data management policies. All data generated from this study will be used solely for the primary research objectives of this trial, and will not be disclosed to external third-party researchers without additional ethical approval and explicit patient consent.
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First People's Hospital of Hangzhou