Recruiting

Study on Azacitidine for Patients with Myelodysplastic Syndrome After Stem Cell Transplantation

Verified siteRegistered drugNo 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 a condition known as myelodysplastic syndrome (MDS). MDS is a group of disorders caused by poorly formed or dysfunctional blood cells. The study will use a treatment called Azacitidine, which is a medication in the form of a powder that is mixed into a liquid and injected under the skin. Azacitidine is used to help improve blood cell production and reduce the need for blood transfusions in patients with MDS.

The purpose of this study is to prevent clinical events such as relapse or death in patients who have minimal residual disease (MRD) after undergoing a procedure called allogeneic stem cell transplantation. This procedure involves replacing diseased bone marrow with healthy stem cells from a donor. The study will monitor patients to see if the treatment with Azacitidine can help reduce the risk of these events.

Participants in the study will receive Azacitidine and will be closely monitored over a period of time to assess their response to the treatment. The study aims to determine the effectiveness of Azacitidine in preventing relapse and improving survival rates in patients with MDS who are MRD positive. The trial will also look at the safety of the treatment and its impact on the overall health of the participants.

The research process

The trial runs in 4 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, the patient must have signed an informed consent form, be at least 18 years old, and be eligible for stem cell transplantation.
The patient must have a diagnosis of myelodysplastic syndrome (MDS), mixed myelodysplastic/myeloproliferative syndrome, or acute myeloid leukemia (AML) with myelodysplasia-related dysplasia and 20-29% marrow blasts.
Female patients of childbearing potential must have a negative pregnancy test within two weeks prior to inclusion in the study.
Step 2
Treatment initiation
The patient will receive treatment with azacitidine, administered subcutaneously.
The dosage, frequency, and duration of azacitidine administration will be determined based on the patient's specific condition and response to treatment.
Step 3
Monitoring and adjustments
The patient's response to treatment will be monitored regularly to assess the presence of minimal residual disease (MRD).
Treatment adjustments may be made based on MRD markers to prevent clinical events such as relapse or non-relapse death.
Step 4
Follow-up and evaluation
The primary endpoint is the percentage of clinical events, defined as relapse or non-relapse death, at 12 months from verified MRD positivity.
Secondary endpoints include relapse-free survival, incidence and severity of graft-versus-host disease (GVHD), and overall survival.

Who can join the trial?

5 criteria

You must sign a document called an informed consent, which means you agree to participate in the study after understanding what it involves.
You need to be at least 18 years old.
You should be eligible for a procedure called stem cell transplantation, which is a treatment that replaces damaged or diseased cells with healthy ones.
You must have a condition called myelodysplastic syndrome (MDS), or a related condition like mixed myelodysplastic/myeloproliferative syndrome, or acute myeloid leukemia (AML) with specific characteristics.
If you are a woman who can have children, you need to have a negative pregnancy test within two weeks before joining the study.

Who cannot join the trial?

5 criteria

Patients with a condition called myelodysplastic syndrome cannot participate. This is a group of disorders caused by poorly formed or dysfunctional blood cells.
Patients who are not in the age range of 3 to 4 years old are excluded.
Patients who are not part of the specific clinical trial group identified by the code "2" are excluded.
Both male and female patients can participate, but if a patient does not meet other criteria, they will be excluded.
Patients who are considered part of a vulnerable population are excluded. This means groups of people who might be at a higher risk of harm or exploitation.

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Verified sites

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Aarhus University Hospital
Verified
Aarhus, Denmark
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

Trial locations

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Investigated drugs

Allogeneic Stem Cell Transplantation
is a procedure where a patient receives stem cells from a donor. This therapy is used to replace damaged or diseased bone marrow with healthy stem cells, which can help in treating conditions like myelodysplastic syndrome (MDS). The goal is to restore the patient's ability to produce healthy blood cells and improve their immune system.
Minimal Residual Disease (MRD) Markers
are specific indicators used to detect small numbers of cancer cells that might remain in a patient's body after treatment. In this trial, these markers are used to monitor patients after they have received a stem cell transplant. By identifying MRD-positive patients, doctors can adjust treatments to prevent relapse or other complications.

Azacitidine

What is already known about the treatment

Azacitidine – Azacitidine is administered as an injection under the skin or into a vein. It is currently used in medical practice and is well-documented in medical literature for its role in treating myelodysplastic syndrome. The main therapeutic indication for Azacitidine is to help improve blood cell counts and reduce the need for blood transfusions in patients with this condition. At the molecular level, Azacitidine works by incorporating into RNA and DNA, leading to the inhibition of DNA methylation and promoting the reactivation of tumor suppressor genes. It is classified as a hypomethylating agent in pharmacology.

Investigated diseases

Myelodysplastic syndrome – This is a group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when something goes wrong in the bone marrow, where blood cells are produced. Over time, the bone marrow becomes less effective at producing healthy blood cells, leading to symptoms like fatigue, infections, and easy bruising or bleeding. The disease can progress slowly or quickly, and in some cases, it may transform into a more aggressive form of blood cancer known as acute myeloid leukemia. The progression and symptoms can vary widely among individuals, making it a complex condition to manage.