A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
This research study is for children aged 1 to 17 who have Acute Lymphoblastic Leukaemia (ALL) that has returned for the first time. We want to learn more about a new study medicine called Inotuzumab Ozogamicin (InO). The main aim is to see if InO works better than the usual treatment (ALLR3) in helping children recover after their first cycle of treatment. We will also check how safe InO is and understand its long-term effects. Around 100 children will take part, with two out of three receiving InO. Treatment lasts for one cycle, but we will follow up on their health for up to five years. This study is important because it could help us find better ways to treat this type of ALL in children.
At a glance
What is this study about?
This study is about a type of blood cancer in children called Acute Lymphoblastic Leukaemia (ALL). Specifically, it's for children aged 1 to 17 whose ALL has come back for the first time. When cancer comes back, doctors often need to try different treatments.
Here, we are looking at a new medicine called Inotuzumab Ozogamicin (often shortened to InO). We want to compare it with one of the standard treatments currently used (which is called ALLR3). The main goal is to find out if InO is more effective than ALLR3 in helping children get better after their first cycle of treatment for the returning ALL. We also want to understand if InO is safe and how well children tolerate it, as well as its effects over a longer period.
This is a 'Phase 2' study, which means it's one of the earlier stages of testing new medicines. It helps us understand if the new treatment is promising enough to be studied in larger groups of people. Finding new and better treatments for ALL is very important for children and their families.
Key takeaways
- Targets children aged 1-17 with ALL that has come back.
- Compares a new medicine (InO) with a standard treatment.
- Aims to find out if InO is more effective and safe.
- Treatment lasts one cycle; follow-up for up to 5 years.
- Participation involves random assignment to one of two treatments.
- Could help find better treatments for children with this type of ALL.
Who may be eligible?
This study is looking for children and young people between 1 and under 18 years old. They must have a type of blood cancer called B-cell precursor Acute Lymphoblastic Leukaemia (BCP ALL) that has come back for the first time.
There are specific requirements about when the ALL first came back and certain genetic features it might have. This is all to make sure the study includes children who could benefit most from the treatments being tested. Also, the cancer has to show certain markers (CD22-positive) and involve the bone marrow in a specific way.
To join, children must also be generally well enough to take part, with their body systems like kidneys and liver working properly. A doctor will check all these criteria carefully to see if a child is a good fit for the study.
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 your child aged between 1 and under 18 years?
- Has your child's Acute Lymphoblastic Leukaemia (ALL) come back for the first time?
- Does your child's ALL have specific features that make them suitable for the study?
- Are your child's kidneys and liver working well enough for them to participate?
- Is your child's heart health good enough for the study treatments?
What does participation involve?
If a child joins this study, they will be randomly assigned to receive either the new medicine (Inotuzumab Ozogamicin) or the standard treatment (ALLR3). This will happen after one cycle of treatment. Two out of every three children will receive the new medicine. The treatment will only last for one cycle, which is about 28 days.
After this first cycle, doctors will check how well the treatment worked. If the treatment helped, the child would then move on to other standard treatments decided by their own doctor. If the treatment didn't work as hoped, the doctor would discuss other options. All children in the study will be followed up for safety and long-term health for up to five years, even if their study medicine has finished.
Potential risks and benefits
Locations (74)
- St. Anna KinderspitalVerified postcodeVienna, Austria· Recruiting
- Cliniques universitaires Saint-LucVerified postcodeBrussels, Belgium· Recruiting
- UZ GentVerified postcodeGhent, Belgium· Recruiting
- UZ LeuvenVerified postcodeLeuven, Belgium· Recruiting
- Detska nemocnice FN BrnoVerified postcodeBrno, Czechia· Recruiting
- Fakultni Nemocnice Motol a HomolkaVerified postcodePrague, Czechia· Recruiting
- RigshospitaletVerified postcodeCopenhagen, Denmark· Recruiting
- Helsinki university hospitalVerified postcodeHelsinki, Finland· Recruiting
- Centre Hospitalier Universitaire de Nice - Hôpital l'ArchetVerified postcodeNice, France· Recruiting
- CHU Strasbourg-Hautepierre, Service d'hematologie oncologie pediatrique, pediatrie 3Verified postcodeStrasbourg, France· Recruiting
- Bordeaux University Hospital - PellegrinVerified postcodeBordeaux, France· Recruiting
- CHU de Toulouse - Hôpital des Enfants - Hemato-Immuno-OncologieVerified postcodeToulouse, France· Recruiting
Common questions
What is Acute Lymphoblastic Leukaemia (ALL)?
ALL is a type of cancer that affects white blood cells called lymphocytes. It's the most common type of childhood cancer.
What does 'first relapse' mean?
It means the cancer has come back for the first time after a period of being in remission (when the cancer was not detectable).
What is Inotuzumab Ozogamicin (InO)?
InO is a new medicine being studied. It's designed to target specific cancer cells.
Will my child definitely get the new medicine?
No, children are randomly assigned to either the new medicine or a standard treatment. Two out of three children will receive the new medicine.
How long will my child be in the study?
The study medicine is given for one cycle (about a month). However, your child will be followed up for their health for up to five years after starting the study.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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