RecruitingPHASE3INTERVENTIONAL

Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

This study is for children and teenagers with acute lymphoblastic leukaemia (ALL). Researchers want to find safer, more effective treatments because current strong chemotherapy, while often successful, can have significant side effects. The study uses new approaches, including smart drugs called immunotherapy (like blinatumomab) that target cancer cells specifically, and other targeted medicines (like bortezomib). These new treatments are being tested as alternatives or additions to traditional chemotherapy, especially for those patients at higher risk of the leukaemia returning. The goal is to reduce long-term side effects while maintaining or improving cure rates, making treatment more individual and gentler for young patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Martin Schrappe

Enrolment target

5,000

Start

15 Jul 2018

Estimated completion

14 Jul 2028

Acute Lymphoblastic Leukemia, Pediatric

What is this study about?

Acute lymphoblastic leukaemia (ALL) is a type of cancer that affects the blood and bone marrow. It's the most common cancer in children and teenagers. While treatments have become very good, leading to over 80% of children being cured, the strong chemotherapy used can cause many side effects, sometimes quite serious ones. Researchers have learned a lot more about ALL recently, finding that it's actually many different types under one name, and each type might respond best to different treatments. This means we can start to personalise treatment more.

This study, called AIEOP-BFM ALL 2017, is looking for better, kinder ways to treat ALL. The main idea is to use an 'integrated approach' where doctors look more closely at the specific type of leukaemia a child has. This helps them choose the most effective treatment for that child. A big part of this study is testing new types of medicines, especially ones called 'smart drugs' or 'immunotherapies.' These drugs, like blinatumomab, work by helping the body's own immune system fight the cancer cells, or by targeting specific weaknesses in the cancer cells (like bortezomib). The hope is that these targeted treatments can do the job of very strong chemotherapy, but with fewer harsh side effects.

The study is particularly looking at how these new treatments can help children who might be at a higher risk of their leukaemia coming back, or who haven't responded as well to initial treatment. For some children, especially those with certain types of ALL, the study is seeing if using these smart drugs instead of some intense chemotherapy, or in addition to less intense chemotherapy, can improve their chances of staying well without enduring very toxic treatments. For others, it's about making sure their treatment plan is precisely right for their specific leukaemia, sometimes by extending specific parts of chemotherapy that are known to be very effective for their type of ALL.

Key takeaways

New study for children and teenagers with ALL.
Aims for kinder, more personalised treatments.
Testing 'smart drugs' (immunotherapy) to reduce harsh chemotherapy.
Focus on improving outcomes and reducing side effects.
Treatment planned based on individual leukaemia type.

Who may be eligible?

This study is for children and teenagers under 18 years old who have been newly diagnosed with acute lymphoblastic leukaemia (ALL). It also includes some rare types of blood cancer that are very similar to ALL and are usually treated in the same way. You need to be diagnosed at one of the hospitals taking part in the study, and your parents or guardians will need to give their written permission for you to join.

There are some reasons why a child might not be able to join. For example, if the leukaemia has a specific genetic change called 'Philadelphia chromosome positive' (Ph+), or if there's another serious illness that would make it unsafe to follow the study's treatment plan. Also, if a child received chemotherapy or strong steroid treatment for more than two weeks just before their ALL diagnosis, or if they are already part of another clinical trial (unless it's an approved trial for supportive care), they usually can't join.

Teenage girls who are pregnant or breastfeeding, or who are sexually active and unwilling to use very effective contraception during and for a year after treatment, also cannot take part. The study needs to make sure it's safe for everyone involved and that the results aren't affected by other treatments or conditions.

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 under 18 years old?
Have you been newly diagnosed with acute lymphoblastic leukaemia (ALL) or a very similar blood cancer?
Are you being treated at a hospital taking part in this study?
Do you not have certain other serious health conditions mentioned by your doctor?
Have you not received chemotherapy or strong steroids for more than two weeks just before your diagnosis?

Answer every question to see your result.

What does participation involve?

If you join this study, your treatment will be planned very carefully based on the type of ALL you have and how it responds to the first parts of treatment. You'll receive a combination of medicines through injections and drips, possibly including new 'smart drugs' or targeted therapies. The specific medicines and how long you receive them will vary depending on your individual leukaemia type and how doctors assess your risk category.

You'll have regular hospital visits, tests, and assessments throughout your treatment. These will include blood tests and possibly bone marrow biopsies to check how the leukaemia is responding. The total duration of treatment for ALL can be quite long, often spanning several months to over two years, but the study will focus on specific treatment phases within this overall period. The study aims to fit these new approaches into the established overall treatment schedule.

Potential risks and benefits

Taking part in a study like this means you might receive a treatment that is newer or different from standard care. The potential benefits could include more effective treatment, or treatment with fewer severe side effects, especially if the new targeted drugs can replace harsher chemotherapy. However, there's always a chance that the new treatment might not work as well as expected, or it could have its own set of side effects that are not yet fully known. Researchers carefully monitor all participants for any side effects. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (115)

Sydney Children's Hospital
Verified postcode
Sydney, Australia· Recruiting
The Children's Hospital at Westmead
Verified postcode
Westmead, Australia· Recruiting
Univ.Klinik für Kinder- und Jugendheilkunde Graz
Verified postcode
Graz, Austria· Recruiting
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck
Verified postcode
Innsbruck, Austria· Recruiting
Kepler Universitätsklinikum
Verified postcode
Linz, Austria· Recruiting
LKH Salzburg
Verified postcode
Salzburg, Austria· Recruiting
St. Anna Kinderspital
Verified postcode
Vienna, Austria· Recruiting
University Hospital Brno
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Brno, Czechia· Recruiting
Regional Hospital České Budějovice
Verified postcode
České Budějovice, Czechia· Recruiting
University Hospital Hradec Králové
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Hradec Králové, Czechia· Recruiting
University Hospital Olomouc
Verified postcode
Olomouc, Czechia· Recruiting
University Hospital Ostrava-Poruba
City only
Ostrava-Poruba, Czechia· Recruiting

Common questions

What is 'ALL'?

ALL stands for Acute Lymphoblastic Leukaemia, which is a cancer of the blood and bone marrow that affects children and teenagers. It stops the body from making healthy blood cells.

What are 'smart drugs' or 'immunotherapy'?

These are medicines that work in clever ways. Immunotherapy helps your body's immune system fight the cancer, while other smart drugs target specific weak spots in the cancer cells, aiming to be gentler than traditional chemotherapy.

Why is this study important?

This study aims to make ALL treatment kinder and more effective. By using new medicines and tailoring treatment to each child, it hopes to reduce severe side effects while keeping cure rates high.

Will I still receive standard treatments?

You will receive a lot of the usual treatments for ALL, but this study is testing if adding or swapping in some of these newer, targeted drugs can improve or lessen the side effects of your overall treatment plan.

Does this mean my current treatment isn't good enough?

No, current treatments are very good at curing ALL. This study is about making treatments even better and safer for the future, building on what we already know works well.

How to find out more

Anja Möricke, MD

a.moericke@pediatrics.uni-kiel.de +4943150020150 Official trial record

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