Master Framework For Relapse or Refractory Acute Myeloid Leukemia
This study, called STREAM, is for people with acute myeloid leukaemia (AML) where their cancer has returned or hasn't responded to treatment. It's an important project that simply collects information from patients at participating hospitals across Europe. Scientists want to understand how new treatments are working in real life. Usually, studies involve giving new medicines, but this one just gathers details about your care and health journey. This helps doctors learn more about the best ways to treat AML that has come back or is hard to treat, ultimately aiming to improve care for everyone with this condition. Your involvement helps build a clearer picture for the future.
At a glance
What is this study about?
Acute myeloid leukaemia (AML) is a type of cancer that affects the blood and bone marrow. While treatments have improved over the years, sometimes the cancer can come back (called 'relapse') or not respond well to initial treatment (called 'refractory'). When this happens, it can be very challenging to treat, and there isn't one set standard treatment that works for everyone. This new study aims to gather important information about how different treatments are working for patients in this situation.
The STREAM study is a way to collect information from patients across Europe who have AML that has come back or is hard to treat. It's not a study where you'll be given a new medicine or treatment; instead, it's about observing and recording how patients are doing with the treatments they are already receiving from their doctors. By collecting this 'real-world' information, researchers can get a better understanding of which treatments are most effective for different patients, including children, older adults, and those with rare forms of the disease.
This project is part of a larger European effort to improve care for people with AML. The information collected will be used to help doctors and researchers understand the strengths and weaknesses of current approaches. This in turn could lead to better treatment plans and more targeted therapies in the future, ultimately improving the outlook for patients with this type of AML. By carefully observing current care, the study aims to make sure that effective treatments can reach more patients.
Key takeaways
- This study collects real-world information on AML that has relapsed or is hard to treat.
- It's an 'observational' study, meaning no new treatments or tests are given.
- Your medical records help researchers understand what works best for patients.
- The goal is to improve care for future AML patients across Europe.
- All ages from 6 years onwards are welcome, including children and older adults.
- Your privacy is protected, and you can withdraw at any time.
Who may be eligible?
This study is looking for people who have been diagnosed with acute myeloid leukaemia (AML) based on the latest medical guidelines. Specifically, your AML needs to have either come back after treatment (relapsed), not responded well to treatment (refractory), or shown signs of getting worse, even if it's very early (minimal residual disease).
Anyone aged 6 years and older, regardless of whether they are male or female, can potentially take part. Before joining, you or your legal representative will need to understand the study and agree to participate by giving your informed consent. This means agreeing that the study team can collect information about your health and treatment.
There are very few reasons why you might not be able to join. Generally, if you are already taking part in another clinical trial where the study protocol specifically says you cannot be in another study, then you might not be eligible for this one. Otherwise, most people who meet the AML diagnosis criteria outlined above can be included.
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.
- I have been diagnosed with Acute Myeloid Leukaemia (AML).
- My AML has either come back after treatment, isn't responding well, or is showing signs of getting worse.
- I am 6 years old or older.
- I am willing to provide informed consent (or my legal representative is).
What does participation involve?
If you decide to take part in the STREAM study, you won't be asked to do anything new or different in terms of your treatment or hospital visits. This study is purely observational, meaning the researchers will collect information from your existing medical records and follow your health journey as you continue to receive care from your regular doctors.
There will be no extra appointments, tests, or medication given because of this study. You will continue to have your usual check-ups, treatments, and assessments as planned by your medical team for your AML. The study team will simply gather data about your diagnosis, the treatments you receive, and how you are responding over time.
The total duration of your participation isn't set, as the study aims to follow patients through their treatment and beyond to understand long-term outcomes. However, because it's non-interventional, it won't add any burden to your routine care. You always have the right to withdraw from the study at any time without affecting your medical care.
Potential risks and benefits
Locations (38)
- University Hospital AachenVerified postcodeAachen, Germany· Recruiting
- University Hospital GreifswaldVerified postcodeGreifswald, Germany· Recruiting
- University Hospital HalleVerified postcodeHalle, Germany· Recruiting
- University Hospital of RostockVerified postcodeRostock, Germany· Recruiting
- Policlinico Sant'Orsola-MalpighiVerified postcodeBologna, Italy· Recruiting
- Ospedale "A. Perrino"Verified postcodeBrindisi, Italy· Recruiting
- ASST Spedali CiviliVerified postcodeBrescia, Italy· Recruiting
- Azienda Ospedaliera S. Croce e CarleVerified postcodeCuneo, Italy· Recruiting
- Ospedale ValduceVerified postcodeComo, Italy· Recruiting
- ASST CremonaVerified postcodeCremona, Italy· Recruiting
- AOU Universitaria Arcispedale Sant'AnnaVerified postcodeFerrara, Italy· Recruiting
- IRCCS Ospedale Policlinico San MartinoVerified postcodeGenova, Italy· Recruiting
Common questions
What is the STREAM study about?
It's a study that collects information from patients with acute myeloid leukaemia (AML) whose cancer has come back or is hard to treat, to better understand how different treatments work.
Will I get new medicine or treatment in this study?
No, this study is observational. You will continue to receive the standard care and treatments your doctor prescribes for your AML. The study just records that information.
Who can take part in this study?
People aged 6 or older with a confirmed diagnosis of AML that has relapsed (come back) or is refractory (hard to treat) can typically join.
Will my personal information be kept private?
Yes, the study uses special tools to protect your privacy and ensure your health information is shared securely without identifying you.
What happens if I change my mind about participating?
You can withdraw from the study at any time without it affecting your medical care or relationship with your healthcare team.
How to find out more
Oriana Nanni
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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