Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

GRanulocyte Augmented Cord Blood Transplantation for Poor Risk leukaEmia

The GRACE study is looking for adults aged 16 to 55 with acute myeloid leukaemia (AML), a type of blood cancer that hasn't responded well to usual treatments or has specific genetic changes. This study aims to find a new, more effective way to treat AML using a special type of transplant. It combines umbilical cord blood with extra white blood cells called granulocytes. Researchers hope this combination will be better at fighting the cancer and preventing it from coming back after the transplant. The study will first check how safe this new approach is, and then compare its effectiveness to standard treatments. It's built on promising results seen in children with resistant leukaemia.

At a glance

Status

Not yet recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Manchester

Enrolment target

Start

09 Feb 2026

Estimated completion

31 Dec 2029

Acute Myeloid Leukemia Stem Cell Transplantation Stem Cell Transplantation, Hematopoietic Cord Blood Stem Cell Transplantation Cellular Therapy

What is this study about?

The GRACE study is a clinical trial exploring a new approach for adults living with a challenging type of blood cancer called Acute Myeloid Leukaemia (AML). For many with high-risk AML, particularly if the disease is hard to clear with chemotherapy or has certain genetic changes, the cancer often returns, even after a stem cell transplant. This study is designed to improve these outcomes.

The trial is testing a new way to perform a stem cell transplant. Instead of the usual method, participants will receive stem cells from umbilical cord blood. What's new and different about this study is that participants will also be given extra infusions of special white blood cells called granulocytes. These granulocytes are part of your immune system and are thought to help fight off the cancer and prevent it from coming back. This idea comes from a previous study in children with very resistant leukaemia, where combining cord blood with granulocytes showed surprisingly good results.

The GRACE study will happen in two stages. The first stage will carefully check the safety of this new treatment in adults and work out the best amount of granulocytes to give. Researchers had observed that in children, a reaction like a fever or rash seemed to be important for the treatment to work, but they need to make sure this is safe and effective in adults. Once safety is confirmed, the second stage will compare this new treatment to standard transplants to see if it is indeed more effective at keeping the leukaemia away. The study is funded by Blood Cancer UK and will involve three NHS transplant hospitals.

Key takeaways

GRACE is a study for adults (16-55) with high-risk AML.
It tests a new transplant method combining umbilical cord blood with extra 'granulocyte' white blood cells.
The study aims to improve treatment outcomes and prevent AML from returning.
It will first check safety, then compare effectiveness to standard treatments.
Participation involves a transplant, infusions, and at least one year of follow-up.

Who may be eligible?

To join the GRACE study, you generally need to be between 16 and 55 years old and have been diagnosed with Acute Myeloid Leukaemia (AML) that is considered high-risk. This means your AML might not have responded well to initial chemotherapy, or it has certain genetic features that make it harder to treat effectively. Doctors will also check that a suitable umbilical cord blood donation is available for you.

Your overall health and the function of your organs, like your kidneys and heart, need to be good enough to safely undergo the transplant. This means particular tests will be done to ensure you are fit for the treatment. You would also need to agree to use effective contraception if you are able to have children.

There are also reasons why you might not be able to join, such as if you've had a previous stem cell transplant or if your leukaemia has spread to your brain or spinal cord. Certain other serious medical conditions, like severe heart problems or some autoimmune diseases, would also mean you couldn't take part. The study team will review all your medical information carefully to see if GRACE is the right study 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 between 16 and 55 years old?
Do you have Acute Myeloid Leukaemia (AML) that is considered high-risk?
Is your general health and organ function strong enough for a transplant?
Do you have suitable umbilical cord blood available?
Have you not had a previous stem cell transplant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the GRACE study, you will receive a transplant using umbilical cord blood, along with infusions of special white blood cells called granulocytes. Before the transplant, you will undergo standard 'conditioning' treatment, which aims to prepare your body for the new cells. Throughout the study, you'll have regular hospital visits for assessments, blood tests, and to receive your granulocyte infusions. The exact number and timing of these infusions will depend on the study design and your response. You will be closely monitored for any side effects or reactions, especially during the first part of the study which focuses on safety. After your transplant, you will have regular follow-up appointments for at least one year to monitor your health, check for the leukaemia's return, and see how well the new cells are working. The total study duration for each patient will be a minimum of one year after the transplant.

Potential risks and benefits

Participating in research studies like GRACE comes with potential benefits and risks. The main potential benefit is that this new treatment might be more effective at treating your high-risk AML and preventing it from returning, especially if standard treatments haven't worked well. However, this is a new approach, and like all medical treatments, there are potential risks, including side effects from the conditioning treatment, the transplant itself, and the granulocyte infusions (which can cause fever or rash). The study is carefully designed to monitor these risks, especially in the first phase. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

Kings College Hospital NHS Trust
Verified postcode
London, United Kingdom
The Royal Marsden Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom

Common questions

What is high-risk AML?

High-risk AML is a type of acute myeloid leukaemia that is harder to treat or more likely to come back after standard treatments, often due to specific genetic changes.

What are granulocytes?

Granulocytes are a type of white blood cell that are part of your immune system. In this study, they are given to help fight the leukaemia and improve the transplant's success.

How is this different from a normal stem cell transplant?

This study uses umbilical cord blood instead of other stem cell sources, and it adds extra infusions of granulocytes, which is not part of standard transplants.

Will I have a reaction to the granulocytes?

Based on previous experience in children, some patients may experience a fever or rash, which researchers believe could be a sign that the treatment is working. Safety in adults is a key part of this study.

How long would I be involved in the study?

You would be followed for at least one year after your transplant to monitor your health and the treatment's effectiveness.

How to find out more

Johnna Ward GRACE Trial Manager

kch-tr.gracestudy@nhs.net 02032999000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.