Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Graft vs Host Disease Prophylaxis in unrelated donor transplantation: a randomized clinical trial comparing PTCY vs ATG

This research study is looking at ways to make blood stem cell transplants safer and more effective for people with serious blood cancers like AML and MDS. When healthy blood stem cells from a donor are put into a patient, there's a risk of a condition called graft-versus-host disease (GvHD), where the new donor cells attack the patient's body. This study compares two different treatment approaches (PTCY and ATG) given after a transplant to prevent GvHD. By comparing these methods, doctors hope to find out which one works best to help patients live longer, stay free of GvHD, and avoid their cancer coming back. The ultimate goal is to improve the success rates and quality of life for people undergoing these life-saving transplants.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

DKMS Group gGmbH

Enrolment target

640

Start

20 Sep 2024

Graft Vs Host Disease Peripheral Blood Stem Cell Transplantation AML MDS MDS/MPN CMML

What is this study about?

This study is about making a special type of transplant, called a peripheral blood stem cell transplant, as safe and effective as possible. This transplant is often used to treat serious blood cancers like Acute Myeloid Leukaemia (AML), Myelodysplastic Syndromes (MDS), and other mixed leukaemias.

When someone receives healthy blood stem cells from a donor, there's a chance the new cells might see the patient's body as 'foreign' and start to attack it. This is called graft-versus-host disease (GvHD), and it can be a very serious problem. Doctors give treatments to try and prevent GvHD. This study is comparing two different ways to do this: one uses a medicine called cyclophosphamide shortly after the transplant (PTCY), and the other uses a medicine known as ATG (short for Anti-thymocyte globulin) given before the transplant. Both methods also involve other anti-rejection medicines like Tacrolimus and Mycophenolic Acid.

The main goal of this research is to see which of these two approaches helps people live longer and stay free from both GvHD and their cancer coming back after the transplant. By carefully comparing these treatments in a large group of patients, doctors hope to find the best way to prevent GvHD, reduce the risk of cancer returning, and improve the overall success of these vital transplants. This particular phase of the study, called a Phase III trial, means researchers are trying to confirm if one treatment is definitively better than the other.

Key takeaways

Compares two ways to prevent GvHD after a stem cell transplant.
Aims to improve patient survival and reduce GvHD and cancer relapse.
Specifically for adults with certain blood cancers like AML and MDS.
Involves anti-rejection medications such as cyclophosphamide, ATG, Tacrolimus, and Mycophenolic Acid.
Could help make stem cell transplants safer and more effective for future patients.

Who may be eligible?

This study is open to adult patients aged 18 years and older who are receiving a peripheral blood stem cell transplant from an unrelated donor. Both men and women are welcome to take part.

To be eligible, you would likely have a diagnosis of a specific type of blood cancer, such as AML, MDS, MDS/MPN, or CMML. The study is specifically looking at transplant patients who need treatments to prevent graft-versus-host disease (GvHD).

Other specific medical criteria would need to be met, which your transplant team would discuss with you in full detail. It's important to have a comprehensive review of your health and medical history to ensure this study is a suitable and safe 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.

Am I 18 years old or older?
Am I having a blood stem cell transplant from a donor who is not a family member?
Do I have AML, MDS, or a similar blood cancer?
Am I willing to potentially receive one of two different GvHD prevention treatments?
Are my general health and organ functions considered suitable for a transplant and study participation?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of two pre-planned treatment combinations designed to prevent graft-versus-host disease (GvHD) after your blood stem cell transplant. These treatments involve specific medications given around the time of your transplant and possibly for a period afterwards. Your doctors and nurses would closely monitor you, just as they would with any transplant patient.

You would have regular check-ups, scans, and blood tests as part of your standard transplant care. The study would keep track of your health, any side effects you experience, and whether your cancer stays in remission. The total duration of your participation would depend on how your recovery progresses and the follow-up schedule for transplant patients, which typically involves monitoring over several years to understand the long-term results of the transplant and the GvHD prevention strategy.

Potential risks and benefits

Taking part in this study might offer the potential benefit of receiving a GvHD prevention strategy that could be more effective than other standard approaches, potentially leading to better health outcomes and a higher chance of successful recovery. However, like all medical treatments, there are potential risks and side effects associated with the medications used, including cyclophosphamide, ATG, tacrolimus, and mycophenolic acid. These can range from mild discomfort to more serious complications, which your medical team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without affecting your ongoing medical care.

Locations (1)

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

—
Unverified
Germany

Common questions

What is graft-versus-host disease (GvHD)?

GvHD happens when the new healthy cells from a donor in a transplant see your body as 'foreign' and start to attack it. It can affect different parts of your body.

What is a peripheral blood stem cell transplant?

It's a medical procedure where healthy blood-forming cells from a donor are put into your body to replace unhealthy ones, often to treat blood cancers.

What's the difference between PTCY and ATG?

They are different medication strategies used to help prevent GvHD after a transplant. PTCY involves cyclophosphamide given shortly after, while ATG is given before the transplant.

Why is this study important?

It helps doctors find the best way to prevent GvHD after a transplant, which can improve how well patients recover and their chances of getting better long-term.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to one of the treatment groups, and sometimes neither you nor your doctor will know which one until after a decision is made based on the study's findings. This helps ensure fair comparison.