Not recruitingRare disease

Study on WT1 mRNA DC Vaccine to Prevent Relapse in Adults with Acute Myeloid Leukemia

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The treatment being tested is called WT1 mRNA DC, which is a type of cell therapy. This treatment involves using special cells known as dendritic cells that have been modified with a substance called WT1 mRNA. These cells are given to patients through an injection under the skin, known as an intradermal injection.

The purpose of the study is to see if this treatment can help prevent the return of AML after patients have achieved remission, which means the cancer is not currently active. The study will compare the effects of the WT1 mRNA DC treatment with a placebo to determine its effectiveness in prolonging the time patients remain in remission and improving their overall survival.

Participants in the study will receive the treatment over a period of time and will be monitored regularly to assess their health and response to the treatment. The study aims to gather information on how well the treatment works and its impact on the immune system, as well as any changes in the quality of life for the participants. The trial is expected to continue until 2028, providing valuable insights into the potential benefits of this innovative therapy for patients with AML.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria related to acute myeloid leukemia (AML).
The criteria include age, risk of relapse, and previous treatment completion.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current health status.
This includes a review of medical history and a physical examination.
Step 3
Vaccination phase
The treatment involves the administration of WT1 mRNA DC through an intradermal injection.
The purpose of this vaccination is to prevent relapse and prolong survival.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to the vaccination.
This includes blood tests to measure WT1 mRNA levels and immune system activation.
Step 5
Evaluation of outcomes
The primary outcome is overall survival, while secondary outcomes include relapse-free survival and quality of life assessments.
Patient-reported outcomes are collected using specific questionnaires at regular intervals.
Step 6
Completion of the trial
The trial is expected to conclude by November 2028.
Final assessments are conducted to evaluate the long-term effects of the treatment.

Who can join the trial?

5 criteria

Must have a diagnosis of **acute myeloid leukemia (AML)**, which is a type of blood cancer, according to specific criteria set by the World Health Organization (WHO).
Must be an **adult** (18 years or older) who is at a very high risk of the cancer coming back. This can be due to being 60 years or older, having certain unfavorable biological features, or not being eligible or willing to have a **stem cell transplant**.
Must have completed specific treatment options, which include either intensive or low-intensity chemotherapy, and achieved a state called **complete remission**. This means the cancer is not detectable, but blood counts must meet certain levels.
Must have a **WHO performance status** of grade 0, 1, or 2, which is a way to measure how well a person can perform daily activities.
Must not have any psychological, family, social, geographical, or physical conditions that could make it difficult to follow the study's requirements and schedule.

Who cannot join the trial?

10 criteria

Patients who have not achieved remission, meaning their cancer is not currently under control.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding, as the study may pose risks to the baby.
Patients who are unable to follow the study procedures or instructions.
Patients who have participated in another clinical trial recently, which could affect the results of this study.
Patients with allergies to any components used in the study treatment.
Patients with a history of other types of cancer, unless they have been in remission for a certain period.
Patients with active infections that require treatment, as this could complicate the study.
Patients with a history of certain heart conditions, as the study treatment may affect the heart.
Patients who have received certain medications recently that could interfere with the study treatment.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Verified
Centre hospitalier universitaire de Liege
Liege, Belgium
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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Investigated drugs

WT1 mRNA-electroporated DC vaccination is a type of immunotherapy used in the clinical trial. This therapy involves using dendritic cells, which are a kind of immune cell, that have been modified with WT1 mRNA. The goal of this vaccination is to help the immune system recognize and attack cancer cells, specifically in patients with acute myeloid leukemia (AML), to prevent the disease from coming back after remission and to help patients live longer.

Wt1 Mrna Dc

What is already known about the treatment

WT1 mRNA-electroporated DC vaccine – This medication is administered as a vaccine, specifically targeting the Wilms' tumor 1 (WT1) antigen, and is delivered through dendritic cells that have been modified using mRNA electroporation. It is currently being studied in clinical trials, particularly in a phase II trial, to assess its effectiveness in preventing relapse in adult patients with acute myeloid leukemia (AML). The main therapeutic indication is to serve as a post-remission strategy for AML patients, aiming to prolong overall survival and prevent disease recurrence. The mechanism of action involves stimulating the immune system to recognize and attack leukemia cells by presenting the WT1 antigen, thereby enhancing the body's natural defense against cancer. This vaccine falls under the pharmacological classification of cancer immunotherapy.

Investigated diseases

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML progresses quickly and can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease is more common in adults and can vary in its specific genetic mutations and characteristics. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The progression of AML requires careful monitoring to manage its impact on the body.