Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
This study, called ALL SCTped 2012 FORUM, is for children and teenagers in the UK and other countries who have Acute Lymphoblastic Leukaemia (ALL) and need a stem cell transplant. Currently, many young patients receive radiation (TBI) as part of their transplant preparation, which can cause long-term health problems like growth issues or other serious conditions. This research wants to find out if using only chemotherapy instead of radiation before a stem cell transplant works just as well to treat the cancer, but with fewer long-term side effects. The study helps doctors learn the best way to help children beat ALL while protecting their future health, especially focusing on those who have already responded well to initial treatment.
At a glance
What is this study about?
This study is designed for children and teenagers who have a type of blood cancer called Acute Lymphoblastic Leukaemia (ALL) and need a stem cell transplant. After their initial treatment, these young people are in what doctors call 'complete remission' – meaning the cancer cells can't be seen, but they still need a transplant to prevent the cancer from coming back.
Traditionally, preparing for a stem cell transplant often involves a treatment called Total Body Irradiation (TBI), which is a type of radiation therapy. While TBI is effective, it can lead to serious and lasting health problems in growing bodies, such as difficulties with growth, hormones, fertility, and even a higher risk of developing another cancer later in life. This study aims to find out if we can replace TBI with a different treatment plan that uses only chemotherapy drugs. The main goal is to see if this chemotherapy-only approach is just as good at keeping the cancer away, but with fewer harsh long-term side effects.
Because ALL is rare in children and only some need a transplant, it's hard for a single hospital or country to get all the answers. That's why this is a large international study, bringing together many experts and patients from different places. By working together, they hope to find better and safer ways to help young people with ALL live long, healthy lives after their treatment.
Key takeaways
- Study for children/teens with ALL needing a stem cell transplant.
- Compares standard treatment (with radiation) to a new chemotherapy-only approach.
- Aims to reduce long-term side effects like growth issues or future cancers.
- Participants are randomly assigned to one treatment group.
- Involves detailed monitoring and follow-up over several years.
Who may be eligible?
To join this study, children and teenagers must have Acute Lymphoblastic Leukaemia (ALL), but not a specific type called B-ALL. They need to be 18 or younger when diagnosed, and between 4 and 21 years old when they receive the transplant. It's really important that their cancer is in 'complete remission' before the transplant, meaning there are no active signs of leukaemia.
They must also need a stem cell transplant as part of their treatment plan and have a suitable donor. Before they can take part, a parent or legal guardian will need to give written permission, and if the child is old enough, they will also need to agree. They cannot have had a transplant before, or have certain other serious health conditions that would make taking part unsafe.
However, this trial is not suitable for everyone. Children with Hodgkin or Non-Hodgkin Lymphoma cannot participate. Also, if a patient or their family decides against following the study plan, or if they have other serious health problems that would prevent them from coping with the treatment, they wouldn't be able to join. Your doctor can help determine if you or your child might be a good fit for this important research.
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 18 years old or younger at diagnosis, and 4-21 years old for the transplant?
- Does the patient have Acute Lymphoblastic Leukaemia (ALL), but not B-ALL?
- Is the patient's cancer in complete remission (no active signs of leukaemia)?
- Is a stem cell transplant part of the patient's treatment plan?
- Is a suitable donor available for the transplant?
- Has the patient NOT had a stem cell transplant before?
What does participation involve?
If you or your child join this study, you'll be randomly assigned to one of two treatment groups: either the standard treatment that includes radiation, or the new treatment using specific chemotherapy drugs instead. This decision is made like flipping a coin, ensuring a fair comparison between the two approaches. Both groups will receive a stem cell transplant and their progress will be closely monitored.
You will have regular hospital visits, including blood tests, physical exams, and other medical checks, before, during, and after the transplant. The study involves specific chemotherapy drugs (like Treosulfan, Fludarabine, Busulfan, Thiotepa, VP16, Cyclophosphamide) and sometimes other medicines (like ATG Thymoglobulin, Grafalon), depending on the group you're in. The treatment typically takes place over several weeks in the hospital for the transplant itself, followed by years of follow-up appointments to track health and recovery. The total duration of follow-up for the study can be quite long, as doctors need to see the long-term effects of the treatments.
Potential risks and benefits
Locations (119)
- Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABAVerified postcodeBuenos Aires, Argentina· Recruiting
- Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant UnitVerified postcodeLa Plata, Argentina· Recruiting
- Children's Cancer Centre The Royal Children's HospitalVerified postcodeMelbourne, Australia· Active not recruiting
- Princess Margaret Hospital for ChildrenVerified postcodePerth, Australia· Active not recruiting
- Sydney Children's HospitalVerified postcodeRandwick, Australia· Active not recruiting
- Lady Cilento Children's HospitalVerified postcodeSouth Brisbane, Australia· Active not recruiting
- The Children's Hospital at Westmead Oncology UnitVerified postcodeSydney, Australia· Active not recruiting
- Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-OnkologieVerified postcodeGraz, Austria· Recruiting
- Universitätsklinik für Kinder- und JugendheilkundeVerified postcodeInnsbruck, Austria· Recruiting
- St. Anna Children's Hospital, Vienna, AustriaVerified postcodeVienna, Austria· Recruiting
- Belarusian Research Center for Pediatric Oncology, Hematology and ImmunologyVerified postcodeMinsk, Belarus· Recruiting
- Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)Verified postcodeBrussels, Belgium· Recruiting
Common questions
What is Acute Lymphoblastic Leukaemia (ALL)?
ALL is a type of cancer that affects the white blood cells in the bone marrow, which are important for fighting infections.
What is a stem cell transplant?
It's a way to replace unhealthy bone marrow with healthy cells, usually from a donor, to help the body make healthy blood cells again.
Why is this study comparing chemotherapy to radiation?
Doctors want to see if they can effectively cure ALL with fewer long-term side effects by using only chemotherapy instead of radiation, especially in growing children.
Will my child definitely get the new treatment?
No, participants are randomly assigned to either the standard treatment (with radiation) or the new chemotherapy-only treatment. It's like a fair draw.
Can I change my mind about participating?
Yes, you can withdraw your consent for your child to participate at any time, for any reason, without it affecting their care.
How to find out more
Christina Peters, Prof. MD PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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