A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
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|ClinicalTrials.gov Identifier: NCT03911128|
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : March 9, 2022
The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design.
The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study.
The study only includes "standard of care" treatment included in the master protocol.
|Condition or disease||Intervention/treatment|
|Leukemia, Acute Lymphoblastic||Other: Observational|
The aims of the ALLTogether study are to improve survival and quality of survival for children and young adults with ALL. ALL in young people has excellent outcome with >90% survival in children and about 75% in young adults. However, patients still die of disease - after relapse as a result of under-treatment.
Furthermore, a considerable fraction of younger patients are over-treated: All patients risk treatment-related death and some suffer long-term side-effects or secondary cancer. The rates of death from disease and death from therapy are almost the same for children. To show improvement with such good survival, large populations are needed.
Study groups from the five Nordic countries, Estonia and Lithuania (NOPHO), the UK (UKALL), the Netherlands (DCOG), Germany (COALL), Belgium (BSPHO), Ireland (PHOAI), Portugal (SHOP) and France (SFCE) have designed a common treatment protocol as new standard of care for children and young adults with ALL. The risk-stratification is based on a novel, personalised algorithm using clinical characteristics, genetic changes in the leukaemia and response to therapy.
The protocol will, based on a personalised risk-approach, define a platform for diagnosis and treatment onto which randomized as well as non-randomised interventions and translational studies can be added. This platform can also be used by countries joining the collaboration at a later date to prepare for full participation.
High-risk B-lineage patients may be stratified to Chimeric Antigen Receptor T-cell (CAR-T) therapy as an alternative to high-risk blocks and stem-cell transplant to reduce the side-effects.
Translational and other therapy-related research will be promoted by the common master protocol.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||A Treatment Study Protocol of the ALLTogether Consortium for Infants, Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL): a Pilot Study|
|Actual Study Start Date :||August 29, 2019|
|Estimated Primary Completion Date :||August 2028|
|Estimated Study Completion Date :||August 2030|
|Participants with newly diagnosed ALL||
Observational study - no intervention
- Event-free survival (EFS) compared to historical controls [ Time Frame: 5 year ]
- Overall survival (OS) compared to historical controls [ Time Frame: 5 year ]
Biospecimen Retention: Samples With DNA
- Blood/blood plasma
- Cerebrospinal fluid
- Bone marrow
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911128
|Contact: Mats Heyman, M.D. PhD||+46 8 517 704 email@example.com|
|Contact: Karin Flood, M.Sc.||+46 70 321 49 firstname.lastname@example.org|
|Study Chair:||Mats Heyman, M.D. PhD||Karolinska University Hospital|