New vaccine aims to keep leukemia in remission

NCT ID NCT07551037

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

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