RecruitingPHASE3INTERVENTIONAL

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

The ALLTogether study is a big research project for children and young adults (aged 0-45) across Europe who have acute lymphoblastic leukaemia (ALL) – a type of blood cancer. Its main goals are to increase the number of people who recover and to make sure people have a good quality of life during and after treatment. It brings together successful treatment ideas from different countries to create a standard treatment plan. On top of this, the study tests new ways of treating ALL, aiming to find options that are less harsh but just as effective, or that work better at stopping the cancer from coming back.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Mats Heyman

Enrolment target

6,430

Start

13 Jul 2020

Estimated completion

01 Jun 2033

Leukemia, Acute Lymphoblastic

What is this study about?

The ALLTogether study is a very important research project for children and young adults, from babies up to 45 years old, who have a type of blood cancer called acute lymphoblastic leukaemia (ALL). This study brings together the knowledge and experience of top doctors and researchers from many different European countries, including the UK, to create the best possible treatment plan.

The main idea behind ALLTogether is to improve how well people with ALL recover and to make sure they have a good quality of life during and after their treatment. While many young people with ALL do very well, some still tragically don't survive, often because their cancer comes back. On the other hand, some people might receive treatments that are stronger than needed, leading to difficult side effects or long-term health problems. This study tries to find the right balance, making sure everyone gets enough treatment to beat the cancer, but not so much that it causes unnecessary harm.

To do this, the study uses a 'master plan' which includes all the tried-and-tested, successful treatments for ALL. On top of this master plan, the study also includes smaller 'trials' that test new ideas. These trials might look at new medicines or different ways of giving existing treatments. The goal is to find out if these new approaches can lead to even better survival rates, fewer relapses, or reduce unpleasant side effects, making treatment easier for patients.

Key takeaways

ALLTogether is a European study for children and young adults (0-45) with ALL.
It aims to improve survival and reduce long-term side effects.
The study combines the best current treatments with trials of new approaches.
It involves many countries working together.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

This study is for people newly diagnosed with acute lymphoblastic leukaemia (ALL) who are between birth and 45 years old (meaning up to one day before their 46th birthday). Your leukaemia must be one of the types called T-cell or B-cell precursor (BCP) ALL, and it needs to be confirmed by a special lab.

You also need to be a resident of one of the participating countries, like the UK, or planning to move there permanently. There are a few specific situations where you wouldn't be able to join, for example, if you have a very specific type of ALL as a baby called KMT2A-rearranged BCP ALL. If you are a woman who could become pregnant, you'll need a negative pregnancy test before starting treatment.

Quick self-check

Are you newly diagnosed with T-cell or BCP-ALL?
Are you between birth and 45 years old?
Do you live in the UK or another participating country?
Have you discussed your specific ALL type with your doctor to confirm eligibility?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join the ALLTogether study, you’ll receive treatment for your leukaemia under a carefully planned "master protocol." This plan details the standard, highly effective treatments, but there's a chance you might also be part of a smaller trial within the study. This could mean trying a new medicine or a different way of giving treatment. This is known as being "randomised" into an intervention.

The study involves regular visits to your paediatric oncology or adult haematology centre for assessments, blood tests, and to receive your treatment. The exact schedule and duration of your treatment and follow-up will depend on your specific leukaemia type and the treatment plan you are on, but leukaemia treatment can last for several years for children and young adults.

Potential risks and benefits

Participating in this study might offer the benefit of receiving some of the most up-to-date and carefully considered treatments for ALL, and potentially access to newer therapies that aim to reduce side effects or improve chances of recovery. However, like all medical treatments, there are potential risks, including side effects from the medicines, which your care team will explain thoroughly. You will always receive the best available care, as even the standard treatment in this study is considered top-notch. It's important to remember that joining is completely voluntary, and you have the right to withdraw from the study at any time without explaining why, and this will not affect your medical care.

Locations (138)

L'hôpital Universitaire des enfants Reine Fabiola (Huderf)
Brussels, Belgium· Recruiting
Cliniques Universitaires Saint-Luc (UCL)
Brussels, Belgium· Recruiting
University Hospital Antwerp
Edegem, Belgium· Recruiting
University Hospital Ghent
Ghent, Belgium· Recruiting
University Hospital Leuven, Dept of Paediatrics
Leuven, Belgium· Recruiting
CHC MontLégia, Boulevard Patience et Beaujonc 2
Liège, Belgium· Recruiting
CHR de la Citadelle
Liège, Belgium· Recruiting
Aalborg University Hospital, Dept of Paediatrics
Aalborg, Denmark· Recruiting
Aarhus University Hospital
Aarhus, Denmark· Recruiting
Aarhus University Hospital, Child and Adolescent Health
Aarhus, Denmark· Recruiting
Rigshospitalet, Dept of Haematology
Copenhagen, Denmark· Recruiting
Rigshospitalet, Dept of Paediatrics
Copenhagen, Denmark· Recruiting

+126 more sites — see the official record for the full list.

Common questions

What is ALL?

ALL stands for Acute Lymphoblastic Leukaemia, which is a type of cancer that affects the blood and bone marrow in children and young adults.

Why is this study called 'ALLTogether'?

It's called ALLTogether because it combines the knowledge and experiences of doctors and researchers from many European countries to improve treatment for ALL.

Will I definitely get a new kind of treatment if I join?

Not necessarily. Everyone gets the best standard treatment, but some people might also be chosen for an additional trial that tests a new medicine or approach.

How long does treatment usually last in this study?

Treatment for ALL, including in this study, typically lasts for a significant period, often a couple of years, depending on the specific plan for your type of leukaemia.

What if I change my mind about participating?

You are free to leave the study at any point, for any reason, and this decision will not affect the medical care you receive.

How to find out more

Global Clinical Trial Manager ALLTogether1

alltogether.karolinska@regionstockholm.se +46 8 123 700 00 Official trial record

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