New triple therapy offers hope for AML patients
NCT ID NCT07490288
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This study tests a new combination of three drugs (venetoclax, azacitidine, and liposomal mitoxantrone) as the first treatment for adults with newly diagnosed acute myeloid leukemia (AML). About 30 participants will receive this therapy, followed by standard chemotherapy and, for high-risk patients, a stem cell transplant. The goal is to see if this approach is safe and improves remission rates.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- 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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14 to 100 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow) * Age ≥ 14 years, male or female. * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2. * Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment): i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group. ii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine \< 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes \< 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO). Exclusion Criteria: * Acute promyelocytic leukemia with PML::RARA fusion gene. * Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene. * Acute myeloid leukemia with BCR::ABL1 fusion gene. * Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed). * Concurrent active malignancy of other organs (requiring treatment). * Active cardiac disease, defined as one or more of the following: i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms. iv. Uncontrolled or symptomatic congestive heart failure (\> New York Heart Association \[NYHA\] Class 2). * Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis). * Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.
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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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Blood diseases hospital
RECRUITINGTianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Breath test aims to classify leukaemia in hours, not days
- Can a Four-Drug prep make curative transplant safer for older AML patients?
- Gentler transplant prep aims to cure tough blood cancers
- Can a Chemo-Transplant combo rescue patients whose leukemia resists standard treatment?
- Can a liposomal chemo combo improve outcomes before stem cell transplant?
- Can a new drug regimen beat the standard for stem cell transplant complications?