Active not recruitingPHASE3INTERVENTIONAL

A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents

This study is investigating the best way to use a particular medicine called pegaspargase for children and young people suffering from acute lymphoblastic leukaemia (ALL). While ALL is a serious illness, many children and teenagers can be cured. Pegaspargase works by removing a substance called asparagine from the blood, which cancer cells need to survive. The study wants to find out if giving one larger dose or two smaller doses of pegaspargase works better. Some patients will be randomly chosen to receive one of these dose plans during their treatment. For others with higher-risk ALL, a more intensive dosing plan will be used. The main goal is to improve how we treat ALL by finding the most effective way to give this important medicine.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

2,044

Start

19 Sep 2016

Estimated completion

01 Mar 2027

Acute Lymphoblastic Leukemia

What is this study about?

This research is looking into how we can make treatments even better for children and young people diagnosed with a type of blood cancer called Acute Lymphoblastic Leukaemia (ALL). ALL is a serious condition, but it's important to know that most children and many teenagers have a very good chance of being cured.

A key part of treating ALL uses a medicine called L-asparaginase (known as pegaspargase in this study). This medicine works in a clever way: it removes a chemical called asparagine from the blood. Cancer cells rely on asparagine to grow, so by removing it, the medicine effectively 'starves' the cancer cells, causing them to die. While we know this medicine is very effective, doctors use it in slightly different ways across different hospitals and countries. This study wants to find the 'best' way to give it.

The study has a couple of main questions. For many patients, doctors want to find out the best balance between giving one larger dose of pegaspargase or two smaller doses during the initial treatment phases. By comparing these two approaches, they hope to discover which method is more effective and has fewer side effects. Additionally, for patients with more aggressive forms of ALL, the study will use a more intensive dosing plan to give them the best possible start to their treatment. The aim of all this is to ensure every child and young person receives the most effective and safest treatment for their ALL.

Key takeaways

This study explores the best way to give a key ALL medicine called pegaspargase.
It aims to improve treatment for children and young people with ALL.
Patients will either receive one large dose or two smaller doses of pegaspargase, chosen randomly for some.
The medicine works by starving leukaemia cells of a vital chemical.
Even with ALL, most children and many teenagers can be cured.
Your or your child's overall ALL treatment will continue as normal.

Who may be eligible?

To join this study, children and young people need to be between 12 months (1 year) and 18 years old and have a diagnosis of Acute Lymphoblastic Leukaemia (ALL).

There are some specific situations where someone wouldn't be able to join. For example, if they have a very rare type of leukaemia (like Burkitt's leukaemia or infant ALL), or if their leukaemia developed after having cancer treatment before. Also, if they have certain other health conditions, a known allergy to similar medicines, or if a girl or young woman is pregnant, they wouldn’t be eligible.

The research team will need to get written permission from parents or guardians (and from the young person if they are old enough) before any treatment starts. They will carefully check all these details to make sure the study is right for each patient.

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.

Is the patient aged between 12 months (1 year) and 18 years?
Does the patient have a diagnosis of Acute Lymphoblastic Leukaemia (ALL)?
Has the patient NOT had previous chemotherapy for cancer?
Is the patient NOT pregnant (for girls/young women)?
Does the patient NOT have specific rare types of leukaemia (like Burkitt's or infant ALL)?
Does the patient NOT have a known allergy to pegylated medicines?

Answer every question to see your result.

What does participation involve?

If you or your child takes part in this study, you'll receive the standard treatment for ALL, with specific changes to how the pegaspargase medicine is given. For some, a computer will randomly decide whether they receive one larger pegaspargase dose or two smaller doses during certain treatment periods. This happens during the initial treatment, and then again during follow-up parts of the treatment.

You or your child will have regular check-ups, blood tests, and other assessments, just like with standard ALL treatment, to monitor their health and the effects of the medicine. The study will follow you or your child throughout their ALL treatment journey, which can last for a considerable time. The exact duration will depend on the standard treatment plan for ALL.

Potential risks and benefits

Taking part in any study involves careful consideration. The potential benefit here is that researchers will learn more about the best way to give an important leukaemia medicine, which could help improve treatments for future patients and potentially for you or your child. As a research study, there's always a chance of unknown side effects or that the chosen dose of medicine might not work as well as expected, although researchers are using established treatments. You or your child will be closely monitored for any side effects or concerns. It’s very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting the medical care you or your child receives.

Locations (28)

CHU
Verified postcode
Amiens, France
CHU
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Angers, France
CHRU
Verified postcode
Besançon, France
CHU
Verified postcode
Bordeaux, France
CHU
Verified postcode
Brest, France
CHU
Verified postcode
Caen, France
CHU
Verified postcode
Clermont-Ferrand, France
CHU
Verified postcode
Dijon, France
CHU
Verified postcode
Grenoble, France
CHU
Verified postcode
Lille, France
CHU
Verified postcode
Limoges, France
Chu-Ihope
Verified postcode
Lyon, France

Common questions

What is Acute Lymphoblastic Leukaemia (ALL)?

ALL is a type of cancer that affects the white blood cells. These cells grow too quickly and stop the body from making healthy blood cells.

What is pegaspargase?

It's a medicine used to treat ALL. It works by removing a substance called asparagine from the blood, which leukaemia cells need to survive.

Why are they studying different ways to give the medicine?

Doctors want to find out if giving the medicine in one larger dose or two smaller doses works better and is safer for patients with ALL.

Will I or my child still get standard ALL treatment?

Yes, this study focuses on how one specific medicine (pegaspargase) is given, while you or your child will still receive the overall standard ALL treatment plan.

Can I stop being part of the study at any time?

Yes, you can choose to leave the study at any point without it affecting the medical care you or your child receives.