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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Miss
Shared account
ALLTogether study
ctc.alltogether@ucl.ac.uk
Dr
John
Moppett
John.Moppett@uhbw.nhs.uk
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Acute Lymphoblastic Leukaemia (ALL) is the commonest cancer of children and young adults with over 400 cases diagnosed each year in the UK. While over 90% of children with ALL are cured, some people’s disease is harder to treat than others. ALLTogether1 investigates whether treatment can be reduced for children with the highest chance of cure, and whether the addition of new drugs improves the chance of cure for those whose disease is most likely to relapse. In the UK, ALLTogether1 will be open to patients aged 1-29 with newly-diagnosed ALL.
Initially, patients will have standard chemotherapy and be registered for data collection only. Based on routine tests carried out before and during the early stages of chemotherapy, patients will be put into one of four risk groups based on how likely their disease is to relapse, for whom standard treatment and the questions that we want to ask will differ. There will also be further research questions for patients with specific needs, such as those whose leukaemia has genetic changes that can be targeted with particular drugs and patients with down syndrome.
Children with standard risk and intermediate risk-low disease can take part in randomisations about whether one or two drugs can safely be removed from their standard treatment. Patients with intermediate risk-high disease can take part in a randomisation about whether adding Inotuzumab Ozogamicin to treatment can safely improve their chance of cure. We will be collaborating with researchers undertaking CAR-T cell trials and will aim to signpost young people with high risk disease to such studies.
The trial will recruit approximately 8000 children and young people across Europe over a six-year period. Each patient will be on trial for at least 5 years (2 years of treatment, then a minimum of 3 years follow-up).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Immunotherapy;
You can take part if:
You may not be able to take part if:
1. Age < 365 days at diagnosis (infant ALL) or >45 years at diagnosis. 2. Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN). 3. Relapse of ALL. 4. Patients with mature B-ALL (as defined by Surface Ig positivity or documented presence of one of the t(8;14), t(2;8), t(8;22) translocations and breakpoint as in BALL). 5. Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR-ABL1 fusion transcript). These patients will be transferred to an adequate trial for t(9;22) if available. 6. ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory. 7. Treatment with systemic corticosteroids (>10mg/m2 /day) for more than one week and/or other chemotherapeutic agents in a 4-week interval prior to diagnosis (pretreatment). 8. Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment). 9. Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures. 10. Women of childbearing potential who are pregnant at the time of diagnosis. 11. Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required, see section 17.7. 12. Female patients, who are breast-feeding. 13. Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair). For each intervention/randomisation an additional set of exclusion-criteria is provided. Patients who are not eligible according to the in- or exclusion criteria above will not be protocol-patients. However, in the case the treating physician considers the ALLTogether protocol their best available SOC, they may be treated according to the protocol at the discretion of the treating physician. Furthermore, they may be registered in a separate database of the ALLTogether consortium for non-protocol patients if this registration is compatible with the legal framework of the country in question and informed consent for this registration is obtained.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
John
Moppett
John.Moppett@uhbw.nhs.uk
Miss
Shared account
ALLTogether study
ctc.alltogether@ucl.ac.uk
The study is sponsored by University College London and funded by CANCER RESEARCH UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 43741
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