Can a liposomal chemo combo outsmart tough leukemias?
NCT ID NCT07735117
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This phase 3 trial compares two drug combinations for adults with a high-risk form of myelodysplastic syndrome (MDS-IB2) or newly diagnosed acute myeloid leukemia (AML) that is either secondary to prior treatment or occurs in older age. One group receives a standard regimen of azacitidine plus venetoclax, while the other gets a newer combination: mitoxantrone hydrochloride liposome, cytarabine, G-CSF, and venetoclax. The main goal is to see which approach leads to a higher rate of complete remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of mitoxantrone hydrochloride liposome, cytarabine, G-CSF, and venetoclax
- What this could lead to
- If successful, this could offer a more effective treatment option for people with high-risk MDS or AML who are older or have secondary disease, potentially improving remission rates.
- What could go wrong
- This is an early-phase trial with a relatively small number of participants. The combination therapy may cause significant side effects, and it is not yet known if it will lead to better long-term outcomes.
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 168 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 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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18 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: * 1\. The patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF). 2\. Age: 18-75 years inclusive. 3. Patients with clinically confirmed adult AML or MDS-IB2 (according to WHO 2022 criteria or ICC 2022 criteria). AML patients must meet any of the following: 1. Therapy-related AML 2. Prior history of MDS 3. Presence of MDS-related genetic/chromosomal abnormalities 4. Prior history of CMML 5. Age ≥ 60 years 6. Prior history of antecedent MPN (including ET, PV, and MF) with bone marrow fibrosis ≤ grade 2 (on a 0-3 grade scale) 4. For elderly AML patients, comprehensive assessment must show they belong to the Fit population: ECOG \< 3, CCI ≤ 0, and MMSE and SPPB assessment results meeting the Fit population criteria. 5\. Liver and kidney function: ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver infiltration); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver infiltration); serum creatinine ≤ 1.5 × ULN. 6\. Expected survival ≥ 3 months. 7. Prior MDS-related therapy (excluding blood transfusions) must be completed at least 2 weeks before the start of study treatment. In cases of rapidly proliferative disease, hydroxyurea is permitted up to 24 hours before the start of study treatment. Toxicities from prior MDS therapy must have recovered to Grade 2 or lower before the start of study treatment. Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from the study: 1. Prior anti-cancer treatment history meeting any of the following: 1. Prior treatment with mitoxantrone or mitoxantrone liposome. 2. Prior treatment with venetoclax or hypomethylating agents. 3. Prior treatment with doxorubicin or other anthracyclines, with a cumulative doxorubicin dose \> 360 mg/m\^2 (for other anthracyclines, 1 mg doxorubicin is equivalent to 2 mg daunorubicin or 0.5 mg idarubicin). 4. Received anti-cancer treatment including surgery, chemotherapy, targeted therapy, etc., or participated in another clinical trial with investigational drug within 4 weeks or 5 half-lives before the first dose of study drug. 2. Cardiac function or disease meeting any of the following: 1. Long QTc syndrome or QTc interval \> 480 ms. 2. Complete left bundle branch block, second-degree or third-degree atrioventricular block. 3. Severe, uncontrolled arrhythmia requiring medication. 4. New York Heart Association (NYHA) Class ≥ II. 5. Left ventricular ejection fraction (LVEF) \< 50%. 6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months before enrollment, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 3. Concurrent uncontrolled malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, carcinoma in situ of breast/cervix, or other malignancies that have been effectively controlled without treatment for \> 6 months and patients receiving long-term non-chemotherapy treatment (e.g., hormone therapy). 4. Uncontrolled systemic disease (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus). 5. Central nervous system (CNS) leukemia. 6. Secondary AML with bone marrow fibrosis ≥ grade 3. 7. Blast crisis of chronic myeloid leukemia (CML). 8. AML with favorable-risk karyotypes: t(8;21)(q22;q22.1) RUNX1::RUNX1T1, inv(16)(p13.1q22) CBFB::MYH11, or acute promyelocytic leukemia (APL). 9. Human immunodeficiency virus (HIV) infection (HIV antibody positive). 10. Active hepatitis B or hepatitis C infection (HBsAg or HBcAb positive with HBV-DNA \> 1×10\^3 copies/mL; HCV antibody positive with HCV-RNA \> 1×10\^3 copies/mL). 11. Known immediate or delayed hypersensitivity reaction to the study drug's class or excipients.
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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?