International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
The "IntReALL BCP 2020" study is exploring new treatments for children whose B-Cell Acute Lymphoblastic Leukaemia (ALL) has returned. It focuses on using special medicines called immunotherapy, like Inotuzumab ozogamicin and Blinatumomab. These new treatments are designed to target cancer cells more directly, aiming to be less harsh on the body than traditional chemotherapy. The main goal is to improve the chances of recovery and keep the leukaemia away for longer, while also reducing the side effects children experience. This research hopes to make these gentler, yet effective, treatments the standard care for children with relapsed B-Cell ALL in the future.
At a glance
What is this study about?
When children get leukaemia, which is a cancer of the blood, doctors try very hard to treat it. While treatments have gotten much better over the years, sometimes leukaemia, especially a type called B-Cell Acute Lymphoblastic Leukaemia (B-Cell ALL), can come back. When this happens, it's called a relapse. Sadly, relapsed ALL can be very serious, and doctors are always looking for better and safer ways to treat it. Current treatments often involve strong chemotherapy and sometimes a bone marrow transplant, which can have significant side effects on growing bodies.
This study, called "IntReALL BCP 2020," is a major effort to find kinder, more targeted treatments for children with relapsed B-Cell ALL. Instead of only using strong chemotherapy, the study is investigating two specific medicines: Inotuzumab ozogamicin and Blinatumomab. These are known as 'immunotherapies' because they work by using the body's own immune system or special tailored antibodies to find and fight cancer cells. The idea is that these newer treatments might be just as effective, or even more so, at getting rid of the leukaemia, but with fewer harsh side effects.
The main aim is to improve the chances of children getting into remission (where the leukaemia can't be found) and staying well for longer, while also making their treatment journey easier. If these immunotherapies prove to be very effective and less toxic, they could become the standard way doctors treat children with relapsed B-Cell ALL in the future, replacing some of the more intensive chemotherapy that is currently used.
Key takeaways
- Exploring new, targeted treatments (immunotherapies) for childhood relapsed B-Cell ALL.
- Aims to be gentler and more effective than traditional chemotherapy.
- Potential to improve long-term recovery and reduce side effects.
- Designed for children whose leukaemia has returned for the first time.
- Could establish these new approaches as standard care in the future.
Who may be eligible?
To join this study, children need to have a specific type of leukaemia called '1st relapsed B-cell precursor ALL.' This means their leukaemia has come back for the first time. They should be at least 1 year old and under 18 when they were first diagnosed, and under 21 when they join the study. It's important that they haven't taken part in another clinical trial in the last 30 days that might affect this study, unless it was for their first leukaemia treatment.
There are also some specific requirements depending on the child's situation. For example, some parts of the study are for children whose leukaemia has come back in the bone marrow and has certain markers. Other parts are for children whose leukaemia has come back somewhere else in the body, outside the bone marrow, without affecting the bone marrow too much.
Children generally can't join if they have certain heart problems, or if they are pregnant or breastfeeding (where applicable). Also, if they've had a bad reaction to similar drugs before, they might not be able to participate, though sometimes a different medicine can be used instead.
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 21 years?
- Has your child been diagnosed with B-Cell ALL that has returned for the first time?
- Has your child previously had any specific heart problems?
- Is your child currently taking part in another clinical research study?
- Does your child have any known severe allergies to medicines?
- Is your child able to come to regular hospital visits?
What does participation involve?
Taking part in this study would involve regular hospital visits for assessments, tests, and to receive the study medications. The exact number and frequency of visits, as well as the types of tests (like blood tests or scans), would depend on the specific treatment plan for your child and the stage of their treatment. You would be given a detailed schedule by the study team.
The treatments involve receiving either Inotuzumab ozogamicin or Blinatumomab, which are usually given through a drip (intravenous infusion). While on the study, your child's health would be closely monitored for any side effects and to see how well the treatment is working. This would include tests to check for signs of leukaemia and to measure their overall health. There would also be a follow-up period after the main treatment is finished to continue monitoring your child's health and recovery.
Potential risks and benefits
Locations (20)
- St. Anna Kinderspital GmbHVerified postcodeVienna, Austria
- Ghent University HospitalVerified postcodeGhent, Belgium
- Fakultni Nemocnice V MotoleVerified postcodePrague, Czechia
- RigshospitaletVerified postcodeCopenhagen, Denmark
- HUS Helsinki University HospitalVerified postcodeHelsinki, Finland
- CHU de NICE, Hôpital L'ARCHETVerified postcodeNice, France
- Charité - Universitätsmedizin BerlinVerified postcodeBerlin, Germany
- Semmelweis UniversityVerified postcodeBudapest, Hungary
- Tel Aviv Sourasky Medical Centre Dana-Dwek Children's HospitalVerified postcodeTel Aviv, Israel
- Ospedale Pediatrico Bambino GesuVerified postcodeRome, Italy
- Prinses Máxima CentrumVerified postcodeUtrecht, Netherlands
- University WroclawVerified postcodeWroclaw, Poland
Common questions
What is B-Cell ALL?
B-Cell Acute Lymphoblastic Leukaemia (ALL) is a type of cancer that starts in the white blood cells called lymphocytes in the bone marrow, specifically B-cells. It can develop quickly.
What is 'relapsed' leukaemia?
Relapsed leukaemia means the cancer has returned after a period of being in remission (when no cancer could be found).
What are Inotuzumab ozogamicin and Blinatumomab?
These are special medicines called immunotherapies. They are designed to find and attack specific markers on leukaemia cells, aiming to be more targeted than traditional chemotherapy.
Will my child still get chemotherapy?
This study aims to use the new immunotherapy drugs to replace some of the strong chemotherapy. The exact treatment plan will depend on your child's specific situation and the part of the study they join.
What are the main goals of this study?
The main goals are to improve recovery rates, keep leukaemia away for longer, and reduce the harsh side effects for children with relapsed B-Cell ALL by using kinder, more targeted treatments.
How to find out more
Adriane E Napp, Dr. rer. medic, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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