AuthorisedTherapeutic confirmatory (Phase III)Interventional

CAALL-F01: a French protocol for the treatment of acute lymphoblastic leukemia (ALL) in children and adolescents

This study, called CAALL-F01, is designed for children and teenagers (from 12 months to under 18 years old) who have recently been diagnosed with standard or medium-risk acute lymphoblastic leukemia (ALL). ALL is a type of blood cancer. The main goal is to find the best way to give a medicine called pegaspargase. Researchers want to see if the medicine works well and if it causes any serious side effects. This study is taking place in several hospitals across France and closely compares different ways of using pegaspargase. It will help doctors understand how to treat ALL more effectively and safely for young patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

1,636

Start

10 Oct 2024

This is a prospective French multicenter open-label design stratified on the immunophenotypic characterization (B- or T- lineage) and the patient risk group that aims at evaluating the efficacy and the tolerance of different schedules of pegaspargase in patients from 12 months to less than 18 years newly diagnosed with standard/medium-risk ALL

What is this study about?

This study, named CAALL-F01, is looking at how best to treat a type of blood cancer called acute lymphoblastic leukemia, or ALL, in children and teenagers. ALL affects the white blood cells and is the most common cancer in children. This study specifically includes young people from 12 months old up to their 18th birthday who have recently been diagnosed with what doctors call 'standard' or 'medium-risk' ALL.

The main medicine being studied is called pegaspargase. It's a key part of ALL treatment. The researchers want to try out different ways of giving this medicine to see which approach works best. They are looking at two key things: firstly, whether enough of the medicine gets into the body to do its job (this is called 'adequate asparaginase activity'), and secondly, whether it causes any serious side effects. This is important to make sure the treatment is both effective and as safe as possible for young patients.

This is a 'Phase III' study, which means it's a large, important study comparing the new approaches with standard treatments. It's being conducted in hospitals across France and is 'open-label,' meaning both the doctors and the patients will know which treatment is being given. The results from this study will help doctors around the world decide on the best way to use pegaspargase to treat children and teenagers with ALL.

Key takeaways

Study for children and teenagers (12 months to under 18) with ALL.
Testing different ways to give pegaspargase medicine.
Looking for how well the medicine works and if it causes side effects.
Aims to improve ALL treatment for young patients.
You can stop participating at any time.

Who may be eligible?

This study is looking for children and teenagers who have recently been diagnosed with a type of blood cancer called acute lymphoblastic leukemia (ALL).

To be considered for the study, participants must be between 12 months old and just under 18 years old. They also need to have been diagnosed with 'standard' or 'medium-risk' ALL, which is a way doctors classify the cancer based on certain features.

This study includes both boys and girls who meet these age and diagnosis requirements.

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 person between 12 months and under 18 years old?
Has the person recently been diagnosed with acute lymphoblastic leukemia (ALL)?
Has the doctor called this 'standard' or 'medium-risk' ALL?

Answer every question to see your result.

What does participation involve?

If you or your child decides to take part in this study, the doctors will be testing different schedules for giving a medicine called pegaspargase. You'll have regular hospital visits for treatments and checks. Doctors will take blood samples to make sure the medicine is working and to watch for any side effects. They will be particularly looking for the medicine's activity in the body around day 33 of the first stage of treatment. They will also closely monitor for specific side effects like blood clots, inflammation of the pancreas, allergic reactions, and liver issues, especially between day 12 and day 49 of treatment, and before a certain point in the next treatment stage. The total length of your participation in the study will depend on the specific treatment plan and follow-up needed.

Potential risks and benefits

Taking part in a clinical trial might offer the benefit of receiving some of the newest treatment approaches for ALL, which could potentially be more effective. However, there are also risks, as pegaspargase can cause side effects like blood clots, inflammation of the pancreas, allergic reactions, and liver problems. The medical team will carefully monitor participants for these and other potential side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your or your child's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is acute lymphoblastic leukemia (ALL)?

ALL is a type of cancer that affects the white blood cells in your body. It's the most common cancer in children and teenagers.

What is pegaspargase?

Pegaspargase is a medicine often used to treat ALL. It works by targeting cancer cells.

What does 'Phase III' mean for a study?

Phase III means it's a large study, usually comparing a new treatment or way of giving a treatment to the standard one, to see which is best.

Will I know which treatment my child is getting?

Yes, this study is 'open-label,' meaning both you and your doctors will know which treatment schedule your child is receiving.

What are the main things doctors are looking for in this study?

Doctors are mainly looking to see if the pegaspargase medicine works well enough ('adequate activity') and if it causes any serious side effects.