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

Summary

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.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

DRUG

Intervention for Venetoclax

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.

DRUG

Intervention for Homoharringtonine

Intravenous infusion of homoharringtonine at a dose of 1 mg/m² daily from Day 1 to Day 7 of each induction cycle.

DRUG

Intervention for Azacitidine

Subcutaneous or intravenous administration of azacitidine at a dose of 75 mg/m² daily from Day 1 to Day 7 of each induction cycle.

DRUG

Intervention for G-CSF

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.

Sponsors & Collaborators

• The Affiliated People's Hospital of Ningbo University

  collaborator OTHER_GOV

• Zhejiang University

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Jinhua Central Hospital

  collaborator OTHER

• Shaoxing People's Hospital

  collaborator OTHER

• Shaoxing Second Hospital

  collaborator OTHER

• Jinhua People's Hospital

  collaborator OTHER

• Dongyang People's Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Huzhou Central Hospital

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• The Second Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• Yuyao People's Hospital

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• Zhejiang Provincial Tongde Hospital

  collaborator OTHER

• First People's Hospital of Hangzhou

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2028-03-31

Completion

2029-03-31

Countries

• China

Study Locations