Triple therapy aims to boost leukemia remission in seniors
NCT ID NCT07469046
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This Phase 3 trial will test whether adding homoharringtonine to the standard two-drug regimen of venetoclax and azacitidine improves remission rates in adults aged 60-75 with newly diagnosed acute myeloid leukemia (AML). About 308 participants will be randomly assigned to receive either the two-drug or three-drug combination. The main goal is to see if the triple therapy leads to more complete remissions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Venetoclax, azacitidine, and homoharringtonine (drug combination)
- What this could lead to
- If this works, it could offer a more effective treatment option for older adults with acute myeloid leukemia, potentially leading to higher remission rates.
- What could go wrong
- This is an early-stage Phase 3 trial that hasn't started recruiting yet. Adding a third drug may increase side effects, and it's unclear if the benefits will outweigh the risks for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 308 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 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. Exclusion Criteria: * 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. * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a liposomal drug combo improve AML treatment for older adults?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Can an Anti-Inflammation drug make AML chemotherapy work better?
- Can a new drug trio overcome venetoclax resistance in leukemia?
- Can engineered cells beat relapsed blood cancers?
- Can a new pill outsmart resistant leukemia?