Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
This research study, called Interfant-21, is for babies under one year old diagnosed with a type of blood cancer called acute lymphoblastic leukaemia (ALL) or mixed phenotype acute leukaemia (MPAL). Specifically, it focuses on babies whose cancer has a particular genetic change called KMT2A-rearranged. The study is trying to find out if adding a medicine called blinatumomab to their usual treatment can improve how well they do. After their initial treatment, all babies in the study will receive a round of blinatumomab. Some babies, depending on how they respond and the risk level of their cancer, might have more blinatumomab or different treatments like a stem cell transplant. The main goal is to make treatments more effective and give these young patients a better chance at recovery.
At a glance
What is this study about?
This study is called Interfant-21, and it's looking into new ways to treat a type of blood cancer called acute lymphoblastic leukaemia (ALL) or mixed phenotype acute leukaemia (MPAL) in babies under one year old. These conditions happen when the body makes too many faulty white blood cells. This study focuses on babies whose cancer has a specific genetic change called a KMT2A-rearrangement, which can make the cancer harder to treat.
The main idea behind this study is to see if adding a new drug, called blinatumomab, to the standard treatment can help these babies get better. Doctors are always looking for ways to improve treatments, especially for very young patients. They hope that blinatumomab might make the standard treatments more effective and lead to better long-term outcomes for these little ones.
Researchers will carefully watch how babies respond to blinatumomab by checking for very small amounts of cancer cells that might still be present. Depending on these checks and other factors, a baby might receive more cycles of blinatumomab or, if needed, a different type of treatment called a stem cell transplant. Everything is done with the aim of giving each baby the best possible care tailored to their situation.
Key takeaways
- This study is for babies under one year old with a specific type of leukaemia.
- It's testing if adding blinatumomab improves treatment outcomes.
- Babies will receive blinatumomab alongside their standard leukaemia care.
- Treatment plans may vary based on how well your baby responds.
- The aim is to find better ways to treat this illness in infants.
Who may be eligible?
This study is specifically designed for very young babies, from birth up to their first birthday, who have been newly diagnosed with a particular type of blood cancer. This cancer must be either B-precursor Acute Lymphoblastic Leukaemia (ALL) or B-cell Mixed Phenotype Acute Leukaemia (MPAL).
Crucially, the cancer must also have a specific genetic change called a KMT2A-rearrangement. This is a very important detail that doctors will check to see if a baby can join the study. Parents or legal guardians must also agree to their baby taking part by providing their written permission.
There are also reasons why a baby might not be able to join. For example, if their cancer does not have the KMT2A-rearrangement, or if they have another type of leukaemia called T-ALL, they wouldn't be eligible. Babies older than one year at diagnosis, those with Down syndrome, or those whose leukaemia has returned (relapsed) are also not able to take part. Also, if a baby has already received certain strong treatments before diagnosis, they might not be able to join the part of the study using blinatumomab.
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 baby newly diagnosed with B-precursor ALL or B-cell MPAL?
- Does their cancer have the KMT2A-rearrangement genetic change?
- Is your baby 365 days old or younger?
- Have you *not* had certain strong treatments before this diagnosis?
- Is your baby *not* diagnosed with Down syndrome or T-ALL?
- Has your baby's leukaemia *not* returned after previous treatment?
What does participation involve?
If your baby joins this study, they will receive their usual standard treatments for leukaemia. On top of this, after their first phase of treatment is finished (called induction therapy), they will be given one course of the study drug, blinatumomab.
Doctors will then carefully check how well your baby's cancer is responding by looking for any remaining cancer cells. If they respond well and are considered to be at a 'medium risk' level, they might receive a second course of blinatumomab later on, which would replace one course of their usual chemotherapy. If the response isn't as good, or if they are at 'high risk', doctors might suggest other treatments, such as a stem cell transplant. Throughout the study, your baby will have regular checks to monitor their health and how the treatment is working. The total duration of participation will depend on the individual treatment plan, but involves long-term follow-up.
Potential risks and benefits
Locations (115)
- Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"Verified postcodeBuenos Aires, Argentina· Suspended
- Australian and New Zealand Children's Haematology/Oncology GroupVerified postcodeClayton, Australia· Recruiting
- North Adelaide- Womens and Childrens HospitalVerified postcodeAdelaide, Australia· Active not recruiting
- Monash Children's HosptialVerified postcodeClayton, Australia· Active not recruiting
- New Lambton Heights- John Hunter Children's HospitalVerified postcodeNew Lambton Heights, Australia· Active not recruiting
- Royal Children's Hospital (Children's Cancer Centre)Verified postcodeParkville, Australia· Active not recruiting
- Perth Children's HospitalVerified postcodePerth, Australia· Recruiting
- Queensland Children's HospitalVerified postcodeSouth Brisbane, Australia· Active not recruiting
- Sydney Childrens HospitalVerified postcodeSydney, Australia· Active not recruiting
- The Childrens Hospital at WestmeadVerified postcodeWestmead, Australia· Active not recruiting
- Medical University Of GrazVerified postcodeGraz, Austria· Active not recruiting
- Medical University Of InnsbruckVerified postcodeInnsbruck, Austria· Recruiting
Common questions
What is KMT2A-rearranged ALL?
It's a specific type of blood cancer in babies where the leukaemia cells have a particular genetic change called a KMT2A-rearrangement, which is important for how the cancer is treated.
What is blinatumomab?
Blinatumomab is a medicine that helps the body's immune system recognise and fight cancer cells. In this study, it's being tested to see if it can improve outcomes for babies with certain types of leukaemia.
Will my baby still receive their regular leukaemia treatment?
Yes, babies in this study will continue to receive their standard leukaemia treatment. Blinatumomab is given in addition to, or in some cases, in place of part of their regular chemotherapy.
What is a stem cell transplant?
A stem cell transplant is a treatment where healthy blood-forming cells are given to your baby to replace unhealthy ones, usually after high-dose chemotherapy. It's a more intensive treatment option.
Can I take my baby out of the study at any time?
Yes, you can decide to withdraw your baby from the study at any point, and this decision will not affect the quality of their ongoing medical care.
How to find out more
Lieke van den Wildenberg
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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