Acute Myeloid Leukemia (AML)Phase 3NCT07469046
VAH vs VA in Newly Diagnosed Elderly AML
A Phase 3 study testing Venetoclax, Azacitidine and Homoharringtonine in people with Acute Myeloid Leukemia (AML) and Elderly Patients (60-75 Years), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a multicenter, open-label, randomized, controlled phase III clinical trial designed to evaluate the efficacy and safety of the combination of Venetoclax, Azacitidine, and Homoharringtonine (VAH) compared to Venetoclax and Azacitidine (VA) alone in newly diagnosed elderly patients with Acute Myeloid Leukemia… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Elderly Patients (60-75 Years)
- What is being tested?
- Venetoclax, Azacitidine and Homoharringtonine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 31 Mar 2029
- Phase
- Phase 3
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute myeloid leukemia (AML), non-APL, according to the 2022 International Consensus Classification (ICC) criteria.
- Age 60 to 75 years, inclusive.
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
- Adequate organ function unless abnormalities are considered due to leukemic organ involvement:
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN). Oxygen saturation > 92% on room air. Total bilirubin ≤ 3.0 × ULN. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN.
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- If laboratory abnormalities are considered due to leukemic organ involvement, total bilirubin ≤ 5.0 × ULN and ALT/AST ≤ 5.0 × ULN are permitted.
- Female subjects of childbearing potential must be postmenopausal or surgically sterile. Male subjects must agree to use effective contraception or abstain from sperm donation from study start through 90 days after the last dose of study treatment.
- Ability to understand and voluntarily sign an informed consent form prior to any study-related procedures.
Who cannot join
- Prior treatment with hypomethylating agents for myelodysplastic syndrome (MDS). Prior chemotherapy for AML, except hydroxyurea. Prior CAR-T cell therapy.
- Prior investigational therapy for AML.
- Documented history of myeloproliferative neoplasm (MPN).
- Favorable-risk AML according to 2022 European LeukemiaNet (ELN) criteria.
- Known active central nervous system (CNS) involvement of AML.
- Known human immunodeficiency virus (HIV) infection.
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- Active hepatitis B or hepatitis C requiring antiviral therapy. Risk of hepatitis B reactivation (hepatitis B surface antigen positive or hepatitis B core antibody positive without antiviral prophylaxis).
- History of another malignancy within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated with curative intent.
- Unstable systemic disease including unstable angina, cerebrovascular accident, or transient ischemic attack within 3 months prior to screening. Myocardial infarction within 3 months prior to screening. Congestive heart failure New York Heart Association class III or IV. Recent pacemaker implantation. Severe liver, kidney, or metabolic disease requiring ongoing treatment. Pulmonary arterial hypertension. Clinically significant or uncontrolled arrhythmias including persistent atrial fibrillation or flutter, symptomatic ventricular arrhythmias, QTc ≥ 470 ms in males or ≥ 480 ms in females, second- or third-degree atrioventricular block without pacemaker, or arrhythmias requiring continuous antiarrhythmic therapy.
- Malabsorption syndrome or any condition preventing enteral drug administration. Active systemic infection requiring treatment.
- Significant neurological or psychiatric disorders requiring treatment including epilepsy grade 2 or higher, paralysis, aphasia, recent cerebral infarction, severe traumatic brain injury, dementia, Parkinson's disease, or schizophrenia.
- Fertile males or females of childbearing potential unwilling to use effective contraception during treatment and for 12 months after completion of treatment.
- White blood cell count > 25 × 10⁹/L at screening (hydroxyurea permitted to reduce count to meet eligibility).
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
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Shanghai Road
About this study
Official title: Venetoclax, Azacitidine Combined With Homoharringtonine Versus Venetoclax and Azacitidine in Newly Diagnosed Elderly (60-75 Years) Acute Myeloid Leukemia: A Multicenter, Open-label, Randomized, Controlled Clinical Trial
This is a multicenter, open-label, randomized, controlled phase III clinical trial designed to evaluate the efficacy and safety of the combination of Venetoclax, Azacitidine, and Homoharringtonine (VAH) compared to Venetoclax and Azacitidine (VA) alone in newly diagnosed elderly patients with Acute Myeloid Leukemia (AML).
A total of 308 treatment-naïve patients aged 60-75 years with AML (non-APL) will be enrolled and randomly assigned in a 1:1 ratio to either the control arm (VA) or the experimental arm (VAH). The study aims to determine if the addition of Homoharringtonine to the standard VA regimen can improve response rates. To mitigate bias in this open-label study, the primary and key secondary efficacy endpoints will be assessed by an Independent Review Committee or central laboratory blinded to treatment allocation.
- Being tested
- Venetoclax, Azacitidine, Homoharringtonine
- Keywords
- Acute Myeloid Leukemia (AML), Elderly 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.
VenetoclaxDrug
Venetoclax: 100 mg orally on Day 1, 200 mg on Day 2, then 400 mg orally on Days 3-28 of a 28-day cycle (dose ramp-up recommended for newly diagnosed patients).
AzacitidineDrug
Azacitidine: 75 mg/m² subcutaneously or intravenously on Days 1-7.
HomoharringtonineDrug
Homoharringtonine (HHT): 1 mg/m² intravenously on Days 1-7.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: VAH | Experimental | Patients receive Venetoclax, Azacitidine, and Homoharringtonine Receives: Drug: Venetoclax; Drug: Azacitidine; Drug: Homoharringtonine |
| Active Comparator: VA | Active comparator | Patients receive Venetoclax and Azacitidine Receives: Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission Rate (CRc)
The proportion of randomized participants who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), according to the 2022 ELN criteria, from randomization up to the initiation of Cycle 3.
Measured: Up to approximately 8 weeks (from randomization to initiation of Cycle 3; each cycle is planned as 28 days).
Secondary outcomes (6)
Event-Free Survival (EFS)
Time from randomization to morphological relapse, initiation of subsequent therapy (while in CR/CRi), or death
Measured: up to 36 months
Overall Survival (OS)
Time from randomization to death from any cause
Measured: up to 36 months
CR/CRi Rate by Cycle 1 and Cycle 2
Proportion of patients achieving CR/CRi prior to the start of Cycle 2 and Cycle 3
Measured: End of Cycle 1 and end of Cycle 2 (each cycle is planned as 28 days; assessments performed prior to initiation of Cycle 2 and Cycle 3)
Complete Remission (CR) Rate
The proportion of randomized participants who achieve complete remission (CR) according to the 2022 European LeukemiaNet (ELN) criteria.
CR is defined as bone marrow blasts <5%, absence of circulating blasts and extramedullary disease, absolute neutrophil count ≥1.0 ×10⁹/L, and platelet count ≥100 ×10⁹/L.
Participants will be evaluated for CR from randomization through the end of Cycle 3. Participants who do not undergo disease assessment within this period will be considered non-responders for this endpoint.
Measured: From randomization through the end of Cycle 3 (approximately 12 weeks).
Minimal Residual Disease (MRD) Negativity Rate
The proportion of randomized participants who achieve measurable residual disease (MRD) negativity (<0.1%), assessed according to protocol-defined methodology. MRD assessments will be performed on Day 14 (±1 day) of Cycle 1, at the end of Cycle 1 (±3 days), at the end of each subsequent treatment cycle (±7 days), and every 3 months during follow-up after achieving CR/CRi, for up to 2 years after completion of treatment. Participants who are randomized but do not undergo MRD assessment will be considered non-responders.
MRD negativity rates will be compared between treatment groups using the Cochran-Mantel-Haenszel (CMH) test, stratified by age (60-64, 65-69, 70-75 years) and study center. Two-sided 95% confidence intervals will be calculated.
Measured: Up to 2 years after completion of treatment.
Time to First Composite Complete Remission (CR or CRi)
Time to first composite complete remission is defined as the number of days from the date of randomization to the earliest date on which a participant achieves complete remission (CR) or complete remission with incomplete hematologic recovery (CRi).
Measured: From randomization until the first documented CR or CRi during study treatment (up to approximately 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start10 Apr 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 (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469046
- Sponsor's protocol ID
- SHSYXY-202508-VAH-VA
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peyrade F, Gastaud L, Re D, Pacquelet-Cheli S, Thyss A. Treatment decisions for elderly patients with haematological malignancies: a dilemma. Lancet Oncol. 2012 Aug;13(8):e344-52. doi: 10.1016/S1470-2045(12)70234-6.
PubMed 22846839Arber DA, Orazi A, Hasserjian RP, Borowitz MJ, Calvo KR, Kvasnicka HM, Wang SA, Bagg A, Barbui T, Branford S, Bueso-Ramos CE, Cortes JE, Dal Cin P, DiNardo CD, Dombret H, Duncavage EJ, Ebert BL, Estey EH, Facchetti F, Foucar K, Gangat N, Gianelli U, Godley LA, Gokbuget N, Gotlib J, Hellstrom-Lindberg E, Hobbs GS, Hoffman R, Jabbour EJ, Kiladjian JJ, Larson RA, Le Beau MM, Loh ML, Lowenberg B, Macintyre E, Malcovati L, Mullighan CG, Niemeyer C, Odenike OM, Ogawa S, Orfao A, Papaemmanuil E, Passamonti F, Porkka K, Pui CH, Radich JP, Reiter A, Rozman M, Rudelius M, Savona MR, Schiffer CA, Schmitt-Graeff A, Shimamura A, Sierra J, Stock WA, Stone RM, Tallman MS, Thiele J, Tien HF, Tzankov A, Vannucchi AM, Vyas P, Wei AH, Weinberg OK, Wierzbowska A, Cazzola M, Dohner H, Tefferi A. International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data. Blood. 2022 Sep 15;140(11):1200-1228. doi: 10.1182/blood.2022015850.
PubMed 35767897
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax, Azacitidine Combined With Homoharringtonine Versus Venetoclax and Azacitidine in Newly Diagnosed Elderly (60-75 Years) Acute Myeloid Leukemia: A Multicenter, Open-label, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07469046
- Acronym / sponsor ID
- SHSYXY-202508-VAH-VA
- Keywords
- Acute Myeloid Leukemia (AML), Elderly Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 13 Mar 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 is a multicenter, open-label, randomized, controlled phase III clinical trial designed to evaluate the efficacy and safety of the combination of Venetoclax, Azacitidine, and Homoharringtonine (VAH) compared to Venetoclax and Azacitidine (VA) alone in newly diagnosed elderly patients with Acute Myeloid Leukemia (AML).
A total of 308 treatment-naïve patients aged 60-75 years with AML (non-APL) will be enrolled and randomly assigned in a 1:1 ratio to either the control arm (VA) or the experimental arm (VAH). The study aims to determine if the addition of Homoharringtonine to the standard VA regimen can improve response rates. To mitigate bias in this open-label study, the primary and key secondary efficacy endpoints will be assessed by an Independent Review Committee or central laboratory blinded to treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: VAH | Experimental | Drug: Venetoclax, Drug: Azacitidine, Drug: HomoharringtoninePatients receive Venetoclax, Azacitidine, and Homoharringtonine |
| Active Comparator: VA | Active comparator | Drug: Venetoclax, Drug: AzacitidinePatients receive Venetoclax and Azacitidine |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of acute myeloid leukemia (AML), non-APL, according to the 2022 International Consensus Classification (ICC) criteria.
- Age 60 to 75 years, inclusive.
- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
- Adequate organ function unless abnormalities are considered due to leukemic organ involvement:
Key exclusion criteria (13 listed)
- Prior treatment with hypomethylating agents for myelodysplastic syndrome (MDS). Prior chemotherapy for AML, except hydroxyurea. Prior CAR-T cell therapy.
- Prior investigational therapy for AML.
- Documented history of myeloproliferative neoplasm (MPN).
- Favorable-risk AML according to 2022 European LeukemiaNet (ELN) criteria.
- Known active central nervous system (CNS) involvement of AML.
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 |
|---|---|---|
| VenetoclaxVenetoclax: 100 mg orally on Day 1, 200 mg on Day 2, then 400 mg orally on Days 3-28 of a 28-day cycle (dose ramp-up recommended for newly diagnosed patients). | Drug | Active Comparator: VA, Experimental: VAH |
| AzacitidineAzacitidine: 75 mg/m² subcutaneously or intravenously on Days 1-7. | Drug | Active Comparator: VA, Experimental: VAH |
| HomoharringtonineHomoharringtonine (HHT): 1 mg/m² intravenously on Days 1-7. | Drug | Experimental: VAH |
Primary outcome
Composite Complete Remission Rate (CRc)
Time frame: Up to approximately 8 weeks (from randomization to initiation of Cycle 3; each cycle is planned as 28 days).
The proportion of randomized participants who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), according to the 2022 ELN criteria, from randomization up to the initiation of Cycle 3.
6 secondary outcomes
Event-Free Survival (EFS)
Time frame: up to 36 months
Overall Survival (OS)
Time frame: up to 36 months
CR/CRi Rate by Cycle 1 and Cycle 2
Time frame: End of Cycle 1 and end of Cycle 2 (each cycle is planned as 28 days; assessments performed prior to initiation of Cycle 2 and Cycle 3)
Complete Remission (CR) Rate
Time frame: From randomization through the end of Cycle 3 (approximately 12 weeks).
Minimal Residual Disease (MRD) Negativity Rate
Time frame: Up to 2 years after completion of treatment.
Time to First Composite Complete Remission (CR or CRi)
Time frame: From randomization until the first documented CR or CRi during study treatment (up to approximately 12 months).
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 13 Apr 2026.
- Background: PubMed 22846839Peyrade F, Gastaud L, Re D, Pacquelet-Cheli S, Thyss A. Treatment decisions for elderly patients with haematological malignancies: a dilemma. Lancet Oncol. 2012 Aug;13(8):e344-52. doi: 10.1016/S1470-2045(12)70234-6.
- Background: PubMed 35767897Arber DA, Orazi A, Hasserjian RP, Borowitz MJ, Calvo KR, Kvasnicka HM, Wang SA, Bagg A, Barbui T, Branford S, Bueso-Ramos CE, Cortes JE, Dal Cin P, DiNardo CD, Dombret H, Duncavage EJ, Ebert BL, Estey EH, Facchetti F, Foucar K, Gangat N, Gianelli U, Godley LA, Gokbuget N, Gotlib J, Hellstrom-Lindberg E, Hobbs GS, Hoffman R, Jabbour EJ, Kiladjian JJ, Larson RA, Le Beau MM, Loh ML, Lowenberg B, Macintyre E, Malcovati L, Mullighan CG, Niemeyer C, Odenike OM, Ogawa S, Orfao A, Papaemmanuil E, Passamonti F, Porkka K, Pui CH, Radich JP, Reiter A, Rozman M, Rudelius M, Savona MR, Schiffer CA, Schmitt-Graeff A, Shimamura A, Sierra J, Stock WA, Stone RM, Tallman MS, Thiele J, Tien HF, Tzankov A, Vannucchi AM, Vyas P, Wei AH, Weinberg OK, Wierzbowska A, Cazzola M, Dohner H, Tefferi A. International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data. Blood. 2022 Sep 15;140(11):1200-1228. doi: 10.1182/blood.2022015850.
- Individual participant dataSharing planned: No
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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 3 study testing Venetoclax, Azacitidine and Homoharringtonine in people with Acute Myeloid Leukemia (AML) and Elderly Patients (60-75 Years), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 9 inclusion and 13 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 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xianmin Song (（+86）18918029692, shongxm@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Complete Remission Rate (CRc) (time frame: Up to approximately 8 weeks (from randomization to initiation of Cycle 3; each cycle is planned as 28 days).). 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 NCT07469046, which also lists 2 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 13 Apr 2026.