Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

GFM-DACORAL-DLI: ASTX727 and donor lymphocyte infusions (DLI) after allogeneic stem cell transplantation (ALLO SCT) in very high-risk MDS or AML patients

This research study is for adults over 18 who have very serious types of blood cancers, specifically high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukaemia (AML). These patients have already had a stem cell transplant, which is a common treatment for these conditions. The study is exploring a new drug called ASTX727 alongside another treatment called donor lymphocyte infusions (DLI). DLI involves giving the patient immune cells from their donor to help fight any remaining cancer. The main goal is to find out if this combination helps people stay free of their cancer for at least one year after their transplant, and to see how it affects their overall health and survival. It's a Phase II study, meaning researchers are carefully checking its effectiveness and safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Groupe Francophone Des Myelodysplasies

Enrolment target

Start

18 Oct 2024

Patients with high risk myelodysplastic syndrome or acute myeloid leukemia

What is this study about?

This study is looking into a new way to help adults who have high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). These are types of blood cancer that can be very aggressive. Patients taking part in this study will have already received a stem cell transplant, which is a major treatment often used for these conditions.

The study combines a new drug called ASTX727 with a treatment called donor lymphocyte infusions (DLI). After a stem cell transplant, sometimes some cancer cells can remain. DLI is a treatment where immune cells from the original stem cell donor are given to the patient, with the idea that these new immune cells will recognise and attack any remaining cancer cells. The researchers want to see if adding ASTX727 to DLI can improve the chances of staying cancer-free.

The main aim is to see how many people remain free of their cancer one year after their transplant with this treatment. They will also look at how long people live after their transplant and after starting the study. This is a "Phase II" study, which means it’s an early stage of clinical research. The researchers are carefully checking if this new approach is effective and safe for patients with these challenging diseases.

Key takeaways

This study explores a new treatment for high-risk MDS/AML after a stem cell transplant.
It combines a new drug (ASTX727) with an immune treatment (DLI).
The main goal is to see if this combination helps people stay cancer-free longer.
It's a Phase II study, meaning researchers are carefully checking effectiveness and safety.
Participants will have regular check-ups and monitoring.

Who may be eligible?

This study is designed for adults of any age (18 and over). Both men and women can take part.

To be considered for this study, you must have been diagnosed with either high-risk myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). You must also have already received a stem cell transplant from a donor.

The doctors will check several other factors, including your general health, how well your organs are working, and how your body has responded to previous treatments, to make sure the study is a safe and appropriate option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)?
Have you already had a stem cell transplant?
Are you willing to have regular hospital visits and treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive ongoing treatment after your stem cell transplant. This will involve taking the study drug, ASTX727, and receiving donor lymphocyte infusions (DLI). The frequency and duration of these treatments will be carefully decided by the study doctors based on your health and the study plan.

You will have regular hospital visits for check-ups, blood tests, and other assessments to monitor your health, how the treatment is working, and to check for any side effects. These visits will be more frequent at the beginning and then become less frequent over time. The study will track your progress for at least one to two years after your transplant.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new treatment that isn’t yet widely available, which could potentially help keep your cancer from returning after a stem cell transplant. However, all treatments carry risks. ASTX727 and DLI may have side effects, and some could be serious. The study team will explain all known side effects and monitor you closely. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What are MDS and AML?

MDS (Myelodysplastic Syndrome) and AML (Acute Myeloid Leukemia) are types of cancer that affect the blood and bone marrow, where blood cells are made.

What is a stem cell transplant?

A stem cell transplant replaces unhealthy bone marrow with healthy blood-forming cells, usually from a donor, to help your body make new, healthy blood cells.

What is DLI?

DLI stands for Donor Lymphocyte Infusion. It's a treatment where you receive immune cells from your stem cell donor to help fight off any remaining cancer cells.

What is ASTX727?

ASTX727 is a new drug being investigated in this study to see if it can help improve the results of treatment for MDS and AML patients after a stem cell transplant.

How long will I be in the study?

The study will track your progress for at least one to two years after your stem cell transplant, with regular check-ups.