Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Cardiac safety of treosulfan chemotherapy prior to stem cell transplantation in patients with leukemia.

This study is investigating a chemotherapy drug called treosulfan. It's for people who have specific types of blood cancer, like acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS), and are going to have a stem cell transplant. The main goal is to check how safe this drug is for their heart before the transplant. This is one of the first studies in humans to specifically look at this, helping doctors understand if the drug might cause any heart issues. It's an important step in making sure treatments are as safe as possible for patients undergoing these procedures.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Medac Gesellschaft fuer klinische Spezialpraeparate mbH

Enrolment target

Start

18 Oct 2024

Subjects with AML ( Acute myeloid leukaemia) or MDS (Myelodysplastic syndrome) undergoing allogeneic hematopoietic stem cell transplantation

What is this study about?

This study is focused on a chemotherapy drug called treosulfan. Chemotherapy is a powerful medicine used to treat cancer, and it works by destroying cancer cells. In this particular study, treosulfan is being used in people who are about to have a stem cell transplant. A stem cell transplant is a treatment where healthy blood-forming cells are given to a patient after high doses of chemotherapy or radiation have been used to destroy unhealthy cells in their bone marrow. It's often used for certain blood cancers.

The main purpose of this research is to understand how treosulfan affects the heart. Sometimes, strong medications can have side effects, and researchers want to make sure that this chemotherapy drug is safe for the heart before patients go through a stem cell transplant. By carefully checking patients' hearts, doctors can learn more about the drug's safety profile.

This is an early-stage study, meaning it's one of the first times researchers are looking at this specific aspect of treosulfan in people. The results will help doctors better understand the drug and ensure future treatments are as safe and effective as possible for people with blood cancers like acute myeloid leukaemia and myelodysplastic syndrome.

Key takeaways

This study investigates the heart safety of treosulfan chemotherapy.
It's for adults with specific blood cancers (AML or MDS).
Participants will be having a stem cell transplant.
The research aims to improve understanding of treatment safety.
You will receive close heart monitoring if you participate.

Who may be eligible?

This study is open to adults aged 18 and older. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to join.

To be considered for this study, you must have been diagnosed with either Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS). These are both types of blood cancer. You also need to be planning to have a 'allogeneic hematopoietic stem cell transplant'. This is a type of stem cell transplant where the healthy cells come from a donor.

If you meet these general criteria, your care team will be able to check if you're a good fit for the study based on other health factors.

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?
Have you been diagnosed with Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)?
Are you planning to have an allogeneic stem cell transplant (using cells from a donor)?
Are you able to attend extra appointments for heart monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the chemotherapy drug treosulfan as part of your preparation for a stem cell transplant. The study involves a close monitoring schedule to specifically check your heart health. This will likely include regular tests, such as heart scans or ECGs (which check the electrical activity of your heart), both before and after you receive the treosulfan.

You will also have regular blood tests and physical examinations. These appointments will happen at the hospital, usually alongside your standard cancer treatment appointments. The total duration of your active participation, including follow-up checks on your heart, will be explained by the study team, but it will be over a period of weeks to months around your transplant.

Potential risks and benefits

Potential benefits of taking part include getting a specific chemotherapy drug that your doctor believes is suitable for your condition, and contributing to important medical research that could help future patients. However, there's no guarantee that treosulfan will specifically benefit your heart health, as the study is about understanding safety. Potential risks include the known side effects of treosulfan chemotherapy, as well as any discomfort from the extra tests needed to monitor your heart. You will be closely monitored for any side effects. You have the right to withdraw from the study at any time without affecting your standard medical 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
Germany

Common questions

What is treosulfan?

Treosulfan is a chemotherapy medicine used to treat certain cancers, especially before a stem cell transplant.

What is a stem cell transplant?

It's a medical procedure where healthy blood-forming cells are given to replace unhealthy ones, often after high-dose chemotherapy.

Why are you studying the heart?

Researchers want to make sure that the chemotherapy drug treosulfan is safe for the heart and doesn't cause any unexpected problems.

Who can join this study?

Adults aged 18 and over with specific blood cancers (AML or MDS) who are having a donor stem cell transplant.

Is this a new drug?

No, treosulfan has been used for some time, but this study focuses specifically on its safety for the heart in this group of patients.