Exploratory Study of Venetoclax, Homoharringtonine, Azacitidine Plus G-CSF for Newly Diagnosed AML (VHAG)

Sponsor
First People's Hospital of Hangzhou
Study ID
NCT07507825
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intervention for Venetoclax — DRUG
    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.
  • Intervention for Homoharringtonine — DRUG
    Intravenous infusion of homoharringtonine at a dose of 1 mg/m² daily from Day 1 to Day 7 of each induction cycle.
  • Intervention for Azacitidine — DRUG
    Subcutaneous or intravenous administration of azacitidine at a dose of 75 mg/m² daily from Day 1 to Day 7 of each induction cycle.
  • Intervention for G-CSF — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
61 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VHAG Regimen Treatment Arm
    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.

Primary Outcome Measure

CRc（CR+CRi） [ Time Frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56) ]

Central Contacts

Related Studies