Autologous peptide vaccine as maintenance therapy for AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study delivering autologous peptide-induced active immunotherapy to adult AML patients who achieved remission after induction and are receiving routine consolidation/maintenance chemotherapy. Patients receive the peptide immunotherapy in conjunction with their consolidation courses to determine safety and early signs of immune activity and clinical benefit. The trial enrolls adults aged 18–70 with recovered blood counts and an expected survival of at least 12 months. Primary focus is on tolerability and safety, with secondary observations on immune responses and relapse rates.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Meijuan Huang
• Email: huangmj@fjmu.edu.cn
• Phone: 13365910912

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.