Acute Myeloid Leukemia (AML)Phase 2VHAGNCT07507825
Exploratory Study of Venetoclax, Homoharringtonine, Azacitidine Plus G-CSF for Newly Diagnosed AML (VHAG)
A Phase 2 study testing Intervention for Venetoclax, Intervention for Homoharringtonine and Intervention for Azacitidine in people with Acute Myeloid Leukemia (AML), run by First People's Hospital of Hangzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Intervention for Venetoclax, Intervention for Homoharringtonine and Intervention for Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 31 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has fully understood the study, voluntarily participated, and signed the informed consent form (ICF).
- Newly diagnosed acute myeloid leukemia (AML) confirmed by bone marrow morphology, immunophenotyping, cytogenetics, and/or molecular biology testing, in accordance with the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2022 edition).
- No prior systemic therapy for AML (including induction, consolidation, or maintenance therapy).
- Patients judged unfit for standard cytarabine plus anthracycline induction chemotherapy due to age or comorbidities.
- Short-term use of hydroxyurea or low-dose cytarabine before enrollment to control hyperleukocytosis is permitted.
- Age ≥ 75 years, or age 18-74 years with any of the following comorbidities:
Show all 19Show fewer
- ECOG performance status 2-3
- History of congestive heart failure, left ventricular ejection fraction (LVEF) ≤ 50%, or chronic stable angina
- Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% predicted, or forced expiratory volume in 1 second (FEV1) ≤ 65% predicted
- Creatinine clearance 30-45 mL/min (≥ 30 and < 45)
- Moderate hepatic impairment: total bilirubin > 1.5 × ULN and ≤ 3 × ULN
- Other comorbidities deemed unfit for standard chemotherapy by the investigator
- Estimated survival time ≥ 12 weeks.
- For patients aged ≥ 75 years: ECOG performance status 0-2.
- For patients aged 18-74 years: ECOG performance status 0-3.
- Creatinine clearance ≥ 30 mL/min (calculated by the Cockcroft-Gault formula).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 × ULN; may be relaxed to ≤ 3 × ULN in patients with leukemic hepatic infiltration.
- For patients < 75 years old, total bilirubin ≤ 3 × ULN.
Who cannot join
- Acute promyelocytic leukemia (APL).
- History of prior myeloproliferative neoplasms, including polycythemia vera, essential thrombocythemia, myelofibrosis, etc.
- Prior receipt of hypomethylating agents, venetoclax (VEN), or systemic chemotherapy for myelodysplastic syndromes (MDS).
- Prior receipt of any investigational drug or device therapy for MDS/AML.
- Concurrent participation in another clinical trial.
- AML with central nervous system (CNS) involvement confirmed by imaging or cerebrospinal fluid examination.
Show all 16Show fewer
- Positive HIV antibody during the screening period.
- Positive HBsAg or HCV antibody with a high-sensitivity viral load above the lower limit of detection within 3 months (excluding those who are cured or with persistent low-level replication).
- Ingestion of grapefruit, grapefruit juice, Seville oranges, star fruit, or their products within 72 hours prior to the first dose.
- Chronic respiratory failure requiring long-term oxygen therapy.
- Presence of severe cardiac, hepatic, renal, endocrine, metabolic, immune, neurological, or psychiatric disorders.
- History of hypersensitivity to the study drug (including azacitidine excipients).
- Impaired drug absorption due to malabsorption syndrome, short bowel syndrome, or other conditions affecting oral drug absorption.
- Active tuberculosis or other severe infections requiring intravenous anti-infective therapy for ≥7 days.
- Presence of a second malignancy within 2 years prior to enrollment, excluding cured carcinoma in situ of the cervix or breast, completely resected basal cell carcinoma or localized squamous cell carcinoma of the skin, or localized malignancies cured by surgery and requiring no further follow-up.
- The investigator judges that the patient is otherwise ineligible to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, 310006
Peipei Ye, Dr, 86-13685832706, 39612903@qq.com
Xiangmin Tong, Dr
About this study
Official title: A Prospective, Multicenter, Exploratory Study of Venetoclax, Homoharringtonine, and Azacitidine Combined With G-CSF in Elderly or Unfit Patients With Newly Diagnosed Acute Myeloid Leukemia
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.
Read more
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.
Read the detailed description
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
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Intervention for Venetoclax, Intervention for Homoharringtonine, Intervention for Azacitidine, Intervention for G-CSF
- Keywords
- Acute myeloid leukemia (AML), Venetoclax, Homoharringtonine, Azacitidine, Elderly/unfit patients
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for VenetoclaxDrug
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 HomoharringtonineDrug
Intravenous infusion of homoharringtonine at a dose of 1 mg/m² daily from Day 1 to Day 7 of each induction cycle.
Intervention for AzacitidineDrug
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-CSFDrug
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 group | Role | What they receive |
|---|---|---|
| VHAG Regimen Treatment Arm | Experimental | 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. Receives: Drug: Intervention for Venetoclax; Drug: Intervention for Homoharringtonine; Drug: Intervention for Azacitidine; Drug: Intervention for G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRc（CR+CRi）
Composite complete remission (CR) plus CR with incomplete hematologic recovery
Measured: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
Secondary outcomes (5)
ORR（CR+CRi+MLFS+PR）
Objective Response Rate (Complete Response + Complete Response with incomplete hematologic recovery + Marrow Leukemia-Free State + Partial Response)
Measured: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
OS
Overall Survival
Measured: 1year
RFS
Relapse-Free Survival
Measured: 1year
MRD
Rate of negative conversion of evaluable minimal residual disease (MRD)
Measured: 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)
Measured: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label, non-randomized, interventional study. All enrolled subjects will receive the same study regimen consisting of venetoclax, homoharringtonine, azacitidine, and G-CSF (VHAG) according to the protocol-specified schedule. No control or comparator group is included. The intervention model is designed to evaluate the safety and efficacy of the VHAG combination regimen in the target population of newly diagnosed acute myeloid leukemia patients who are elderly or unfit for standard intensive chemotherapy.
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507825
- Sponsor's protocol ID
- 2026IIT031-1
- Acronym
- VHAG
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Yin Z, Gao Y, Bu X, Wang J, Yao Z, Liu Q, Zhang Y, Yu G, Ping B. Homoharringtonine sensitized resistant acute myeloid leukemia cells to venetoclax-induced apoptosis. Leuk Lymphoma. 2024 Dec;65(14):2138-2150. doi: 10.1080/10428194.2024.2400228. Epub 2024 Sep 5.
PubMed 39235111Yu G, Zhang Y, Yu S, Yin Z, Weng G, Xu N, Du X, Lin D, Xiao J, Sun Z, Zhang H, Liang X, Guo Z, Zhao W, Dai M, Fan Z, Xuan L, Liu H, Xu D, Ye J, Jiang X, Shi P, Jin H, Liu Q. Homoharringtonine Added to Venetoclax and Azacitidine Improves Outcome and Mitigates Genetic Impact in Relapsed/Refractory AML: A Multicenter Cohort Study. Clin Cancer Res. 2025 Jan 6;31(1):87-97. doi: 10.1158/1078-0432.CCR-24-1332.
PubMed 39531539DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.
PubMed 32786187Um HD. Bcl-2 family proteins as regulators of cancer cell invasion and metastasis: a review focusing on mitochondrial respiration and reactive oxygen species. Oncotarget. 2016 Feb 2;7(5):5193-203. doi: 10.18632/oncotarget.6405.
PubMed 26621844Choi JH, Bogenberger JM, Tibes R. Targeting Apoptosis in Acute Myeloid Leukemia: Current Status and Future Directions of BCL-2 Inhibition with Venetoclax and Beyond. Target Oncol. 2020 Apr;15(2):147-162. doi: 10.1007/s11523-020-00711-3.
PubMed 32319019Dombret H, Raffoux E, Gardin C. Acute myeloid leukemia in the elderly. Semin Oncol. 2008 Aug;35(4):430-8. doi: 10.1053/j.seminoncol.2008.04.013.
PubMed 18692693Pollyea DA, Kohrt HE, Medeiros BC. Acute myeloid leukaemia in the elderly: a review. Br J Haematol. 2011 Mar;152(5):524-42. doi: 10.1111/j.1365-2141.2010.08470.x.
PubMed 21314823Kantarjian HM, Thomas XG, Dmoszynska A, Wierzbowska A, Mazur G, Mayer J, Gau JP, Chou WC, Buckstein R, Cermak J, Kuo CY, Oriol A, Ravandi F, Faderl S, Delaunay J, Lysak D, Minden M, Arthur C. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012 Jul 20;30(21):2670-7. doi: 10.1200/JCO.2011.38.9429. Epub 2012 Jun 11.
PubMed 22689805Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.
PubMed 25987659Juliusson G, Antunovic P, Derolf A, Lehmann S, Mollgard L, Stockelberg D, Tidefelt U, Wahlin A, Hoglund M. Age and acute myeloid leukemia: real world data on decision to treat and outcomes from the Swedish Acute Leukemia Registry. Blood. 2009 Apr 30;113(18):4179-87. doi: 10.1182/blood-2008-07-172007. Epub 2008 Nov 13.
PubMed 19008455SEER Cancer Stat Facts: Acute Myeloid Leukemia. 2017 2025-12-18]; Available from: https://seer.cancer.gov/statfacts/html/amyl.html.
Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
PubMed 28055103Wang H, Wang X, Shi T, Wei S, Li X, Leng Y, Wu Y, Sun M, He P, Zhu HH. Granulocyte colony-stimulating factor plus venetoclax and azacitidine in newly diagnosed acute myeloid leukemia: a multicenter phase 2 trial. Blood Cancer J. 2025 Oct 27;15(1):184. doi: 10.1038/s41408-025-01389-4. No abstract available.
PubMed 41145434Yin Z, Yao Z, Chen D, Zhang Y, Weng G, Du X, Lin D, Xiao J, Sun Z, Zhang H, Liang X, Guo Z, Zhao W, Xuan L, Jiang X, Shi P, Liu Q, Ping B, Yu G. Homoharringtonine may help improve the outcomes of venetoclax and azacitidine in AML1-ETO positive acute myeloid leukemia. J Cancer Res Clin Oncol. 2024 Jul 6;150(7):336. doi: 10.1007/s00432-024-05861-9.
PubMed 38969948
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Exploratory Study of Venetoclax, Homoharringtonine, and Azacitidine Combined With G-CSF in Elderly or Unfit Patients With Newly Diagnosed Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07507825
- Acronym / sponsor ID
- VHAG / 2026IIT031-1
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute myeloid leukemia (AML), Venetoclax, Homoharringtonine, Azacitidine, Elderly/unfit patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- 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
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label, non-randomized, interventional study. All enrolled subjects will receive the same study regimen consisting of venetoclax, homoharringtonine, azacitidine, and G-CSF (VHAG) according to the protocol-specified schedule. No control or comparator group is included. The intervention model is designed to evaluate the safety and efficacy of the VHAG combination regimen in the target population of newly diagnosed acute myeloid leukemia patients who are elderly or unfit for standard intensive chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| VHAG Regimen Treatment Arm | Experimental | Drug: Intervention for Venetoclax, Drug: Intervention for Homoharringtonine, Drug: Intervention for Azacitidine, Drug: Intervention for G-CSFAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The patient has fully understood the study, voluntarily participated, and signed the informed consent form (ICF).
- Newly diagnosed acute myeloid leukemia (AML) confirmed by bone marrow morphology, immunophenotyping, cytogenetics, and/or molecular biology testing, in accordance with the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2022 edition).
- No prior systemic therapy for AML (including induction, consolidation, or maintenance therapy).
- Patients judged unfit for standard cytarabine plus anthracycline induction chemotherapy due to age or comorbidities.
- Short-term use of hydroxyurea or low-dose cytarabine before enrollment to control hyperleukocytosis is permitted.
Key exclusion criteria (16 listed)
- Acute promyelocytic leukemia (APL).
- History of prior myeloproliferative neoplasms, including polycythemia vera, essential thrombocythemia, myelofibrosis, etc.
- Prior receipt of hypomethylating agents, venetoclax (VEN), or systemic chemotherapy for myelodysplastic syndromes (MDS).
- Prior receipt of any investigational drug or device therapy for MDS/AML.
- Concurrent participation in another clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention for VenetoclaxOral 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 | VHAG Regimen Treatment Arm |
| Intervention for HomoharringtonineIntravenous infusion of homoharringtonine at a dose of 1 mg/m² daily from Day 1 to Day 7 of each induction cycle. | Drug | VHAG Regimen Treatment Arm |
| Intervention for AzacitidineSubcutaneous or intravenous administration of azacitidine at a dose of 75 mg/m² daily from Day 1 to Day 7 of each induction cycle. | Drug | VHAG Regimen Treatment Arm |
| Intervention for G-CSFSubcutaneous 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. | Drug | VHAG Regimen Treatment Arm |
Primary outcome
CRc（CR+CRi）
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
Composite complete remission (CR) plus CR with incomplete hematologic recovery
5 secondary outcomes
ORR（CR+CRi+MLFS+PR）
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
OS
Time frame: 1year
RFS
Time frame: 1year
MRD
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
NCICTCAEv5.0
Time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 39235111Yin Z, Gao Y, Bu X, Wang J, Yao Z, Liu Q, Zhang Y, Yu G, Ping B. Homoharringtonine sensitized resistant acute myeloid leukemia cells to venetoclax-induced apoptosis. Leuk Lymphoma. 2024 Dec;65(14):2138-2150. doi: 10.1080/10428194.2024.2400228. Epub 2024 Sep 5.
- Background: PubMed 39531539Yu G, Zhang Y, Yu S, Yin Z, Weng G, Xu N, Du X, Lin D, Xiao J, Sun Z, Zhang H, Liang X, Guo Z, Zhao W, Dai M, Fan Z, Xuan L, Liu H, Xu D, Ye J, Jiang X, Shi P, Jin H, Liu Q. Homoharringtonine Added to Venetoclax and Azacitidine Improves Outcome and Mitigates Genetic Impact in Relapsed/Refractory AML: A Multicenter Cohort Study. Clin Cancer Res. 2025 Jan 6;31(1):87-97. doi: 10.1158/1078-0432.CCR-24-1332.
- Background: PubMed 32786187DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.
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- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intervention for Venetoclax, Intervention for Homoharringtonine and Intervention for Azacitidine in people with Acute Myeloid Leukemia (AML), run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangmin Tong, DR (86-13750816623, tongxiangmin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRc（CR+CRi） (time frame: After 2 cycles of induction therapy(each cycle is 28 days; approximately Day 56)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07507825, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.