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

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.

NCT Number	NCT07507825
Lead Sponsor	First People's Hospital of Hangzhou Collaborators: The Affiliated People's Hospital of Ningbo University, Zhejiang University, The Central Hospital of Lishui City, Jinhua Central Hospital, Shaoxing People's Hospital, Shaoxing Second Hospital, Jinhua People's Hospital, Dongyang People's Hospital, Taizhou Hospital, Huzhou Central Hospital, Affiliated Hospital of Jiaxing University, The Second Affiliated Hospital of Jiaxing University, Second Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Yuyao People's Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Zhejiang Provincial Tongde Hospital
Conditions	Acute Myeloid Leukemia (AML)
Enrollment	61 participants
Start Date	2026-03-31
Primary Completion	2028-03-31 (estimated)
Study Completion	2029-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-02