Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor
This study is looking into making stem cell transplants safer for older adults (aged 50-70) with certain blood cancers like Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndrome (MDS). These transplants can offer a cure, but they carry a risk of a serious complication called Graft-versus-Host Disease (GVHD), where the new cells attack the patient's body. The trial compares two different medications, Grafalon and Thymoglobulin, which are both used to prevent GVHD. Doctors don't yet know which one is better at controlling GVHD in this specific group of patients, while also being safe. The aim is to find the best way to prevent GVHD, making these life-saving transplants less risky and more successful for older patients.
At a glance
What is this study about?
Stem cell transplants are a very important treatment for some blood cancers, like Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndrome (MDS). For many patients, especially those over 50, this can be the only way to get rid of the cancer for good. During a transplant, you receive healthy stem cells, usually from a donor whose cells are a very good match for yours. Before the transplant, you have treatment to prepare your body to accept these new cells.
One of the main challenges after a stem cell transplant is a serious complication called Graft-versus-Host Disease (GVHD). This happens when the donated healthy cells start to attack the patient's own body tissues, causing a range of problems. To prevent GVHD, patients are usually given medicines. This study is focusing on two specific medicines called Grafalon and Thymoglobulin. Both of these are 'anti-thymocyte globulins' (ATGs) which help to dampen down the immune system to reduce the chance of GVHD.
Doctors know that managing GVHD is very important, but they are still trying to work out which medicine, and what dose, is best for older patients who have had a specific type of stem cell transplant using cells from an unrelated donor. This trial aims to compare Grafalon and Thymoglobulin to see which one is more effective at preventing GVHD in this group of patients, with the goal of making transplants safer and improving overall outcomes.
Key takeaways
- Compares two medicines (Grafalon, Thymoglobulin) to prevent GVHD after stem cell transplant.
- Focuses on patients aged 50-70 with AML or MDS and an unrelated donor.
- Aims to find the safest and most effective GVHD prevention for this group.
- Participation involves receiving one of the two medicines randomly.
- Helps improve future transplant outcomes for older patients.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for people aged between 50 and 70 years old who have Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS) and need a stem cell transplant. You must have a donor whose cells are a very close match (10 out of 10) but who is not a family member. Your general health needs to be good enough to go through a stem cell transplant, for example, your heart, lungs, and other organs should be working well, and any infections must be under control.
There are also some specific health checks. For instance, if you are between 50 and 55 years old, doctors might need to confirm that a stronger type of treatment before the transplant isn't suitable for you. You can't have had certain other cancers recently, or have serious infections like HIV or active hepatitis.
Before you can join, you'll need to sign a consent form, showing you understand the study. If you're a woman who could become pregnant or a man who could father a child, you'll need to agree to use effective contraception throughout the study.
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 50 and 70 years old?
- Do you have Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)?
- Do you need a stem cell transplant from an unrelated, closely matched donor?
- Is your general health good enough for a stem cell transplant?
- Are you willing to use effective contraception if it applies to you?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to receive one of two medicines (Grafalon or Thymoglobulin) to help prevent GVHD after your stem cell transplant. You won't get to choose which one you receive, as this is how studies make sure the comparison is fair.
Your participation will involve regular check-ups and assessments, similar to the care you would usually receive after a stem cell transplant, but with some extra monitoring specific to the study. This will include blood tests and other tests to keep an eye on your recovery, how the new cells are doing, and to check for any signs of GVHD or other complications. The doctors will also be monitoring how effective the GVHD prevention medicine is. All of this will happen during your hospital stay and at follow-up appointments after you go home. The total duration of your involvement will be decided by your medical team based on your recovery and the study's monitoring schedule.
Potential risks and benefits
Locations (28)
- CHU AmiensVerified postcodeAmiens, France· Recruiting
- CHU AngersVerified postcodeAngers, France· Recruiting
- CHU BesançonVerified postcodeBesançon, France· Recruiting
- CHU BordeauxVerified postcodeBordeaux, France· Recruiting
- CHU BrestVerified postcodeBrest, France· Recruiting
- CHU CaenVerified postcodeCaen, France· Recruiting
- CHU Clermont-FerrandVerified postcodeClermont-Ferrand, France· Recruiting
- Hôpital Henri Mondor AP-HPVerified postcodeCréteil, France· Not yet recruiting
- CHU GrenobleVerified postcodeGrenoble, France· Recruiting
- CHU LilleVerified postcodeLille, France· Recruiting
- CHU LimogesVerified postcodeLimoges, France· Recruiting
- CHU Lyon SudVerified postcodeLyon, France· Recruiting
Common questions
What is GVHD?
GVHD stands for Graft-versus-Host Disease. It's a complication after a stem cell transplant where the new, healthy cells from the donor see your body as 'foreign' and start to attack your own tissues and organs.
What are Grafalon and Thymoglobulin?
These are both medicines called 'anti-thymocyte globulins' (ATGs). They work by calming down your immune system to help prevent GVHD after a stem cell transplant.
Why is this study only for older patients?
Older patients (over 50) often have different health considerations, and doctors want to find the safest and most effective GVHD prevention strategy specifically for this age group undergoing this type of transplant.
Will I get to choose which medicine I receive?
No, in this type of study, you'll be randomly assigned to one of the two medicines (Grafalon or Thymoglobulin) to ensure the comparison between them is fair and unbiased.
What kind of donor do I need for this study?
You need a 'matched unrelated donor', meaning someone who is not a family member but whose cells are a very good match (10 out of 10) for yours.
How to find out more
Régis Peffault de Latour, Pr
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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