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New vaccine aims to keep leukemia in remission
NCT ID NCT07551037
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a personalized vaccine made from a patient's own leukemia cells to help prevent the cancer from coming back. It is for adults with acute myeloid leukemia who are in remission after chemotherapy. The vaccine is designed to train the immune system to recognize and attack any remaining leukemia cells.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Sep 2026
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 70 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: * Newly diagnosed with acute myeloid leukemia (AML) in accordance with the 2018 WHO Classification and Diagnostic Criteria for Acute Leukemias; received 1-2 courses of conventional chemotherapy, achieved remission, and are undergoing routine consolidation therapy. * Aged 18 to 70 years. * Receiving a maintenance therapy regimen without hormonal agents. * Leukocyte and lymphocyte counts have basically returned to the normal range. * Patients judged by the investigator to have an expected survival of at least 12 months after achieving remission. * Patients who voluntarily participate in this study and sign the informed consent form. Exclusion Criteria: * Patients who still require hormonal maintenance therapy after achieving remission. * Patients with a concomitant history of other malignant tumors or a history of uncontrolled malignant tumors. * Having participated in other clinical trials within 1 month prior to screening. * Complicated with uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases and other similar conditions. * Having other uncontrolled diseases that the investigator deems unfit for enrollment. * Patients with psychiatric disorders or those known/suspected to be unable to fully comply with the study protocol. * Pregnant or lactating women. * HIV-infected individuals. * Other conditions that the investigator deems may prevent the subject from completing the study or pose a significant safety risk to the subject. Withdrawal Criteria: * Judged by the investigator to be in the best interest of the subject. * Disease progression or initiation of other anti-leukemia therapy. * The subject requests to withdraw from the study for any reason at any time. * Lost to follow-up. * Death. * Occurrence of severe chemotherapy-induced toxic reactions, or chemotherapy delay of more than 4 weeks due to adverse reactions. * Cardiac toxicity: Left Ventricular Ejection Fraction (LVEF) ≤ 50% or a decrease of \> 10%; or QTc prolongation meeting the following criteria: ① QTc \> 500 ms; ② QTc \> 530 ms in patients with bundle branch block. * Hepatic toxicity: Persistent elevation of alanine transaminase (ALT) and/or aspartate transaminase (AST) to more than 2 times the upper limit of normal (ULN), with no response to hepatoprotective treatment.
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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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Fujian Medical University Union Hospital
RECRUITINGFuzhou, Fujian, 350001, China
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