RecruitingPHASE3INTERVENTIONAL

IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

The IMPACT-AML study is exploring better ways to treat acute myeloid leukaemia (AML) in adults where the cancer has returned or didn't get better with previous treatment. It's a large study happening in many hospitals, comparing two main types of treatment: stronger, more intense options and gentler, lower-intensity therapies. The aim is to find out which approach is more effective for patients experiencing their first or second relapse of AML when doctors think either approach could be suitable. This research is important because it could help doctors choose the best treatment plans for people with AML in the future.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Enrolment target

339

Start

27 Feb 2025

Estimated completion

01 Jan 2028

Acute Myeloid Leukemia Relapse/Recurrence

What is this study about?

Acute myeloid leukaemia (AML) is a type of cancer that affects the blood and bone marrow. Sometimes, after treatment, AML can return (this is called a relapse) or it might not respond to the first treatments given (this is called refractory AML). When this happens, doctors need to explore new ways to help patients.

This study, called IMPACT-AML, is looking at different treatment options for adults whose AML has come back, either for the first or second time, or hasn't responded to previous treatments. Researchers want to compare two main approaches: strong, high-intensity treatments, which might involve more powerful chemotherapy, and gentler, low-intensity treatments. These gentler treatments can sometimes be just as effective with fewer side effects.

The main goal is to understand which of these treatment types works better for patients in this situation, helping doctors make more informed decisions about future care. The study is supported by the European Commission, showing its importance in finding better ways to manage AML.

Key takeaways

The study compares stronger and gentler treatments for AML.
It's for adults whose AML has returned or hasn't responded to previous treatment.
Participation helps find better future treatments for AML.
Your treatment group is chosen by chance, not by choice.
All care will be closely monitored by medical professionals.

Who may be eligible?

This study is for adults, aged 18 or over, who have a specific type of AML (not Acute Promyelocytic Leukaemia) that has come back for the first or second time, or hasn't responded to earlier treatments.

To join, your doctor must believe that both the stronger and gentler treatment options could be suitable for you, and that both are available at your local hospital. Importantly, there shouldn't be another treatment that your doctor thinks is definitely better for you right now, or any medical reasons that would prevent you from having either of the study treatments.

You also need to be fit enough to take part. Women who could become pregnant will need to take a pregnancy test and use very effective birth control during the study. Men will also need to use birth control if their partner could become pregnant.

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?
Do you have AML that is not Acute Promyelocytic Leukaemia?
Has your AML come back for the first or second time, or not responded to earlier treatment?
Does your doctor think both stronger and gentler treatment options are suitable for you?
Are you able to use effective birth control if you are a woman who could become pregnant, or a man with a partner who could become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the high-intensity or low-intensity treatment. This is like flipping a coin – it's decided by chance, not by your doctor or your choice. Your doctors will explain the specific treatment plan for you, including any visits, tests, or medication you'll need. The study will monitor your health closely throughout the treatment and for a period afterwards to see how well the treatment is working and if there are any side effects. The total duration of your participation will depend on your specific treatment plan and how your health progresses, but it will involve ongoing assessments as part of your care.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a carefully monitored treatment that could be more effective for your specific condition. You would also be contributing important information that could help many other patients with AML in the future. However, there are potential risks, as all medical treatments have possible side effects, and some treatments might not work as well as hoped. You will be told about all the known risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (47)

University Hospital Brno
Verified postcode
Brno, Czechia· Recruiting
University Hospital Hradec Králové
Verified postcode
Hradec Králové, Czechia· Not yet recruiting
University Hospital Olomouc
Verified postcode
Olomouc, Czechia· Not yet recruiting
University Hospital in Ostrava
Verified postcode
Ostrava, Czechia· Not yet recruiting
University Hospital in Pilsen
Verified postcode
Pilsen, Czechia· Recruiting
Uniklinik RWTH Aachen
Verified postcode
Aachen, Germany· Recruiting
University Hospital Greifswald
Verified postcode
Greifswald, Germany· Recruiting
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Verified postcode
Halle, Germany· Recruiting
University Hospital Halle
Verified postcode
Halle, Germany· Recruiting
University Hospital of Rostock
Verified postcode
Rostock, Germany· Recruiting
Heinrich-Braun-Klinikum gGmbH
Verified postcode
Zwickau, Germany· Recruiting
Policlinico Sant'Orsola
Verified postcode
Bologna, Italy· Recruiting

Common questions

What is Acute Myeloid Leukaemia (AML)?

AML is a fast-growing cancer of the blood and bone marrow, which are found inside your bones and make blood cells.

What does 'relapsed or refractory' mean?

Relapsed means the cancer has come back after treatment. Refractory means the cancer didn't get better with previous treatments.

What's the difference between high and low intensity treatments?

High-intensity treatments are generally stronger, like powerful chemotherapy, aiming to be very effective. Low-intensity treatments are usually gentler, with fewer side effects, but aim to be just as effective.

Why is this study important?

This study aims to find out which treatment approach (stronger or gentler) works best for AML that has come back, helping doctors choose the most effective care for patients in the future.

Will I get to choose my treatment?

No, in this study, the treatment you receive (either high or low intensity) will be chosen at random, like flipping a coin, once you've met all the entry requirements.

How to find out more

Oriana Nanni

cc.ubsc@irst.emr.it +39 0543739100 Official trial record

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