A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
NCT ID: NCT03911128
Last Updated: 2025-09-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-08-29
Study Completion Date
2033-06-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Leukemia, Acute Lymphoblastic
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Participants with newly diagnosed ALL
Observational
Intervention Type
OTHER
Observational study - no intervention
Interventions
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Observational
Observational study - no intervention
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
Exclusion Criteria
* Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2/6 rearrangement. T-ALL patients with MYC translocations.
* Informed consent signed by the patient and/or parents/legal guardians according to country-specific age related guidelines
* The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
* The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.
* The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots and patients who intend to stay at least for the duration of the treatment with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.
* All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.
* Age \< 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and/or a KMT2A fusion transcript). These patients will be transferred to an appropriate trial for infant KMT2A-r BCP-ALL, if available.
* Age \>45 years at diagnosis.
* Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).
* Relapse of ALL.
* Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2/6 rearrangement.
* 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 appropriate trial for t(9;22) if available.
* Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.
* Treatment with systemic corticosteroids corresponding to (\>10mg prednisolone/m2/day) for more than one week and/or other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).
* Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).
* 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.
* Women of childbearing potential who are pregnant at the time of diagnosis.
* 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 18.9.
* Female patients, who are breast-feeding.
* Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).
* Informed consent signed by the patient and/or parents/legal guardians according to country-specific age related guidelines
* The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
* The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.
* The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots and patients who intend to stay at least for the duration of the treatment with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.
* All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.
* Age \< 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and/or a KMT2A fusion transcript). These patients will be transferred to an appropriate trial for infant KMT2A-r BCP-ALL, if available.
* Age \>45 years at diagnosis.
* Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).
* Relapse of ALL.
* Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2/6 rearrangement.
* 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 appropriate trial for t(9;22) if available.
* Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.
* Treatment with systemic corticosteroids corresponding to (\>10mg prednisolone/m2/day) for more than one week and/or other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).
* Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).
* 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.
* Women of childbearing potential who are pregnant at the time of diagnosis.
* 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 18.9.
* Female patients, who are breast-feeding.
* Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).
Minimum Eligible Age
0 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Nordic Society for Pediatric Hematology and Oncology
OTHER
Sponsor Role
collaborator
The Swedish Childhood Cancer Foundation
UNKNOWN
Sponsor Role
collaborator
NordForsk
UNKNOWN
Sponsor Role
collaborator
Mats Heyman
OTHER
Sponsor Role
lead
Responsible Party
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Mats Heyman
MD, Associate Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Mats Heyman, M.D. PhD
Role: STUDY_CHAIR
Karolinska University Hospital
Locations
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Aalborg University Hospital, Dept of Paediatrics
Aalborg, , Denmark
Site Status
ACTIVE_NOT_RECRUITING
Aarhus University Hospital
Aarhus, , Denmark
Site Status
ACTIVE_NOT_RECRUITING
Aarhus University Hospital, Child and Adolescent Health
Aarhus, , Denmark
Site Status
ACTIVE_NOT_RECRUITING
Rigshospitalet, Dept of Haematology
Copenhagen, , Denmark
Site Status
ACTIVE_NOT_RECRUITING
Rigshospitalet, Dept of Paediatrics
Copenhagen, , Denmark
Site Status
ACTIVE_NOT_RECRUITING
Odense University Hospital, Dept of Paediatrics
Odense, , Denmark
Site Status
ACTIVE_NOT_RECRUITING
North Estonia Medical Centre, Dept of Haematology
Tallinn, , Estonia
Site Status
NOT_YET_RECRUITING
Tallinn Children´s Hospital, Dept of Paediatrics
Tallinn, , Estonia
Site Status
NOT_YET_RECRUITING
Tartu University Hospital
Tartu, , Estonia
Site Status
NOT_YET_RECRUITING
Helsinki University Hospital, Dept of Haematology
Helsinki, , Finland
Site Status
ACTIVE_NOT_RECRUITING
Helsinki University Hospital, Dept of Paediatrics
Helsinki, , Finland
Site Status
ACTIVE_NOT_RECRUITING
Kuopio University Hospital, Dept of Haematology
Kuopio, , Finland
Site Status
ACTIVE_NOT_RECRUITING
Kuopio University Hospital, Dept of Paediatrics
Kuopio, , Finland
Site Status
ACTIVE_NOT_RECRUITING
Oulu University Hospital, Dept of Haematology, Dept of Medicine
Oulu, , Finland
Site Status
NOT_YET_RECRUITING
Oulu University Hospital, Dept of Paediatrics
Oulu, , Finland
Site Status
ACTIVE_NOT_RECRUITING
Tampere University Hospital, Dept of Haematology
Tampere, , Finland
Site Status
NOT_YET_RECRUITING
Tampere University Hospital, Dept of Paediatrics
Tampere, , Finland
Site Status
ACTIVE_NOT_RECRUITING
Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit
Turku, , Finland
Site Status
NOT_YET_RECRUITING
Turku University Hospital, Dept of Paediatrics
Turku, , Finland
Site Status
ACTIVE_NOT_RECRUITING
Landspitali University Hospital, Children's Hospital
Reykjavik, , Iceland
Site Status
ACTIVE_NOT_RECRUITING
Children's Hospital, Affiliate of Vilnius University Hospital
Vilnius, , Lithuania
Site Status
ACTIVE_NOT_RECRUITING
Vilnius University Hospital
Vilnius, , Lithuania
Site Status
ACTIVE_NOT_RECRUITING
Haukeland University Hospital, Dept of Haematology
Bergen, , Norway
Site Status
ACTIVE_NOT_RECRUITING
Haukeland University Hospital, Dept of Paediatrics
Bergen, , Norway
Site Status
ACTIVE_NOT_RECRUITING
Oslo University Hospital, Dept of Haematology
Oslo, , Norway
Site Status
ACTIVE_NOT_RECRUITING
Oslo University Hospital, Dept of paediatric haemato- and oncology
Oslo, , Norway
Site Status
ACTIVE_NOT_RECRUITING
Stavanger University Hospital, Dept of Haematology
Stavanger, , Norway
Site Status
ACTIVE_NOT_RECRUITING
University Hospital North Norway, Dept of Haematology
Tromsø, , Norway
Site Status
ACTIVE_NOT_RECRUITING
University Hospital of North Norway, Dept of Paediatrics
Tromsø, , Norway
Site Status
ACTIVE_NOT_RECRUITING
St. Olavs University Hospital, Dept of Paediatrics
Trondheim, , Norway
Site Status
ACTIVE_NOT_RECRUITING
St. Olavs University Hospital, Dept of Haematology
Trondheim, , Norway
Site Status
ACTIVE_NOT_RECRUITING
Hospital Universitario de Cruces
Barakaldo, , Spain
Site Status
RECRUITING
Hospital Universitario San Joan de Déu
Barcelona, , Spain
Site Status
RECRUITING
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Site Status
RECRUITING
Hospital Universitario La Paz
Fuencarral-El Pardo, , Spain
Site Status
RECRUITING
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Site Status
RECRUITING
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Site Status
RECRUITING
Hospital Universitario Virgen del Rocio
Seville, , Spain
Site Status
RECRUITING
Hospital Universitario Politécnico La Fe
Valencia, , Spain
Site Status
RECRUITING
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Site Status
RECRUITING
Sahlgrenska University Hospital, Section for Haematology and coagulation
Gothenburg, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology
Gothenburg, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Linköping University Hospital, Dept of Haematology
Linköping, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Linköping University Hospital, Dept of Paediatrics
Linköping, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Skåne University Hospital, Dept of Haematology
Lund, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Skåne University Hospital, Dept of Paediatrics
Lund, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Örebro University Hospital, Section for Haematology
Örebro, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Karolinska University Hospital, Dept of Paediatric Oncology and Haematology
Stockholm, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Karolinska University Hospital, Patient area Haematology
Stockholm, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Norrland University Hospital, Dept of Haematology
Umeå, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Norrland University Hospital, Dept of Paediatrics
Umeå, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Uppsala University Hospital, Dept of Haematology
Uppsala, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Uppsala University Hospital, Dept of Paediatric Haematology and Oncology
Uppsala, , Sweden
Site Status
ACTIVE_NOT_RECRUITING
Countries
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Denmark
Estonia
Finland
Iceland
Lithuania
Norway
Spain
Sweden
Central Contacts
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Facility Contacts
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Timo Siitonen, M.D.
Role: primary
References
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Toft N, Birgens H, Abrahamsson J, Griskevicius L, Hallbook H, Heyman M, Klausen TW, Jonsson OG, Palk K, Pruunsild K, Quist-Paulsen P, Vaitkeviciene G, Vettenranta K, Asberg A, Frandsen TL, Marquart HV, Madsen HO, Noren-Nystrom U, Schmiegelow K. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia. Leukemia. 2018 Mar;32(3):606-615. doi: 10.1038/leu.2017.265. Epub 2017 Aug 18.
Reference Type
BACKGROUND
Schramm F, Zimmermann M, Jorch N, Pekrun A, Borkhardt A, Imschweiler T, Christiansen H, Faber J, Feuchtinger T, Schmid I, Beron G, Horstmann MA, Escherich G. Daunorubicin during delayed intensification decreases the incidence of infectious complications - a randomized comparison in trial CoALL 08-09. Leuk Lymphoma. 2019 Jan;60(1):60-68. doi: 10.1080/10428194.2018.1473575. Epub 2018 Jul 3.
Reference Type
BACKGROUND
Mondelaers V, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Lutz P, Costa V, Sirvent N, Plouvier E, Munzer M, Poiree M, Minckes O, Millot F, Plantaz D, Maes P, Hoyoux C, Cave H, Rohrlich P, Bertrand Y, Benoit Y; Children-s Leukemia Group (CLG) of the European Organization for Research and Treatment of Cancer (EORTC). Prolonged versus standard native E. coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma: final results of the EORTC-CLG randomized phase III trial 58951. Haematologica. 2017 Oct;102(10):1727-1738. doi: 10.3324/haematol.2017.165845. Epub 2017 Jul 27.
Reference Type
BACKGROUND
Vora A, Goulden N, Wade R, Mitchell C, Hancock J, Hough R, Rowntree C, Richards S. Treatment reduction for children and young adults with low-risk acute lymphoblastic leukaemia defined by minimal residual disease (UKALL 2003): a randomised controlled trial. Lancet Oncol. 2013 Mar;14(3):199-209. doi: 10.1016/S1470-2045(12)70600-9. Epub 2013 Feb 7.
Reference Type
BACKGROUND
Pieters R, de Groot-Kruseman H, Van der Velden V, Fiocco M, van den Berg H, de Bont E, Egeler RM, Hoogerbrugge P, Kaspers G, Van der Schoot E, De Haas V, Van Dongen J. Successful Therapy Reduction and Intensification for Childhood Acute Lymphoblastic Leukemia Based on Minimal Residual Disease Monitoring: Study ALL10 From the Dutch Childhood Oncology Group. J Clin Oncol. 2016 Aug 1;34(22):2591-601. doi: 10.1200/JCO.2015.64.6364. Epub 2016 Jun 6.
Reference Type
BACKGROUND
Other Identifiers
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ALLTogether1 pilot
Identifier Type: -
Identifier Source: org_study_id
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