#1 Clinical Trials Search in Europe

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

2 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Vrije Universiteit Brussel Jette Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Urngwbyrbw Oy Avdaxmu Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
24.06.2013

Trial locations

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.

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.

Trial ID:
2024-515292-35-00
Protocol code:
WIDEA
NCT ID:
NCT01686334
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Venetoclax added to drug combination improves survival in children with relapsed acute myeloid leukemia

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +8

  • Study of Revumenib and Chemotherapy for Patients with Newly Diagnosed Acute Myeloid Leukemia with NPM1 Gene Mutation

    Recruiting

    3 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +7