Leukemia, Acute LymphoblasticNCT03911128
A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
An observational study of Leukemia, Acute Lymphoblastic, run by Mats Heyman at 57 sites in 8 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 45 years
- Conditions the study is for
- Leukemia, Acute Lymphoblastic
- What is being tested?
- Observational
- How many people
- 500 participants
- Where
- 57 sitesin 8 countries
- Study dates
- 29 Aug 2019to Jun 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants 0-45 years with newly diagnosed acute lymphoblastic leukaemia. The protocol has no gender-bias. The total estimated recruitment in the pilot study is 500 participants.
Who may be able to join
- 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.
- Age 0 - < 46 years (one day before 46th birthday) at the time of diagnosis, with the exception of infants with KMT2A-r BCP ALL (see exclusion criteria below).
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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).
Trial locations and contacts
57 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
57 sites in 8 countries
Spain13 sites, 11 recruiting
- Recruiting
Hospital Universitario Dr.Balmis
Alicante
Laura Ureña Horno, M.D.
- Recruiting
Hospital Universitario de Cruces
Barakaldo
Rosa María Adán Pedroso, M.D.
- Active, not recruiting
Hospital Universitario San Joan de Déu
Barcelona
- Active, not recruiting
Hospital Universitario Vall d'Hebron
Barcelona
- Recruiting
Hospital Universitario La Paz
Fuencarral-El Pardo
Berta González Martínez, M.D.
- Recruiting
Hospital Infantil Universitario Nino Jesus
Madrid
Blanca Herrero Velasco, M.D.
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
José Luis Fuster Soler, M.D.
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca
Elena Garcia Macias, M.D.
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander
Mónica López Duarte
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Sheila Torrado González, M.D.
- Recruiting
Hospital Universitario Virgen del Rocio
Seville
Águeda Molinos Quintana, M.D.
- Recruiting
Hospital Universitario Politécnico La Fe
Valencia
Carolina Fuentes Socorro, M.D.
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza
Carmen Rodriguez-Vigil, M.D.
Sweden13 sites
- Completed
Sahlgrenska University Hospital, Section for Haematology and coagulation
Gothenburg, 41345
- Completed
Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology
Gothenburg, 41685
- Completed
Linköping University Hospital, Dept of Haematology
Linköping, 58185
- Completed
Linköping University Hospital, Dept of Paediatrics
Linköping, 58185
- Completed
Skåne University Hospital, Dept of Haematology
Lund, 22185
- Completed
Skåne University Hospital, Dept of Paediatrics
Lund, 22185
- Completed
Örebro University Hospital, Section for Haematology
Örebro, 70185
- Completed
Karolinska University Hospital, Dept of Paediatric Oncology and Haematology
Stockholm, 17176
- Completed
Karolinska University Hospital, Patient area Haematology
Stockholm, 17176
- Completed
Norrland University Hospital, Dept of Haematology
Umeå, 90185
- Completed
Norrland University Hospital, Dept of Paediatrics
Umeå, 90185
- Completed
Uppsala University Hospital, Dept of Haematology
Uppsala, 75185
- Completed
Uppsala University Hospital, Dept of Paediatric Haematology and Oncology
Uppsala, 75185
Finland10 sites, 3 recruiting
- Active, not recruiting
Helsinki University Hospital, Dept of Haematology
Helsinki, 00029
- Active, not recruiting
Helsinki University Hospital, Dept of Paediatrics
Helsinki, 00029
- Active, not recruiting
Kuopio University Hospital, Dept of Haematology
Kuopio, 70029
- Active, not recruiting
Kuopio University Hospital, Dept of Paediatrics
Kuopio, 70029
- Not yet recruiting
Oulu University Hospital, Dept of Haematology, Dept of Medicine
Oulu, 90029
Timo Siitonen, M.D.
Timo Siitonen, M.D.
- Active, not recruiting
Oulu University Hospital, Dept of Paediatrics
Oulu, 90029
- Not yet recruiting
Tampere University Hospital, Dept of Haematology
Tampere, 33521
Johanna Rimpiläinen, M.D.
- Active, not recruiting
Tampere University Hospital, Dept of Paediatrics
Tampere, 33521
- Not yet recruiting
Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit
Turku, 20520
Urpu Salmenniemi, M.D.
- Active, not recruiting
Turku University Hospital, Dept of Paediatrics
Turku, 20520
Norway9 sites
- Active, not recruiting
Haukeland University Hospital, Dept of Haematology
Bergen, 5021
- Active, not recruiting
Haukeland University Hospital, Dept of Paediatrics
Bergen, 5021
- Active, not recruiting
Oslo University Hospital, Dept of Haematology
Oslo, 0372
- Active, not recruiting
Oslo University Hospital, Dept of paediatric haemato- and oncology
Oslo, 0424
- Active, not recruiting
Stavanger University Hospital, Dept of Haematology
Stavanger, 4011
- Active, not recruiting
University Hospital North Norway, Dept of Haematology
Tromsø, 9019
- Active, not recruiting
University Hospital of North Norway, Dept of Paediatrics
Tromsø, 9038
- Active, not recruiting
St. Olavs University Hospital, Dept of Paediatrics
Trondheim, 7006
- Active, not recruiting
St. Olavs University Hospital, Dept of Haematology
Trondheim, 7030
Denmark6 sites
- Active, not recruiting
Aalborg University Hospital, Dept of Paediatrics
Aalborg, 9000
- Active, not recruiting
Aarhus University Hospital
Aarhus, 8000
- Active, not recruiting
Aarhus University Hospital, Child and Adolescent Health
Aarhus, 8200
- Active, not recruiting
Rigshospitalet, Dept of Haematology
Copenhagen, 2100
- Active, not recruiting
Rigshospitalet, Dept of Paediatrics
Copenhagen, 2100
- Active, not recruiting
Odense University Hospital, Dept of Paediatrics
Odense, 5000
Estonia3 sites, 3 recruiting
- Not yet recruiting
North Estonia Medical Centre, Dept of Haematology
Tallinn, 13419
Katrin Palk, M.D.
- Not yet recruiting
Tallinn Children´s Hospital, Dept of Paediatrics
Tallinn, 13419
Kristi Lepik, M.D.
- Not yet recruiting
Tartu University Hospital
Tartu, 50406
Mari Punab, M.D.
Lithuania2 sites
- Active, not recruiting
Children's Hospital, Affiliate of Vilnius University Hospital
Vilnius, 08406
- Active, not recruiting
Vilnius University Hospital
Vilnius, 08661
Iceland1 site
- Active, not recruiting
Landspitali University Hospital, Children's Hospital
Reykjavik, 101
About this study
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
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.
Read the detailed description
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.
- Conditions
- Leukemia, Acute Lymphoblastic
- Being tested
- Observational
- Keywords
- Leukemia, Acute Lymphoblastic, ALL, ALLTogether, Leukaemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational study - no intervention
| Study group | Role | What they receive |
|---|---|---|
| Participants with newly diagnosed ALL | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS) compared to historical controls
Measured: 5 year
Overall survival (OS) compared to historical controls
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start29 Aug 2019
- Primary completionJun 2033 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Acute LymphoblasticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mats Heyman
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Society for Pediatric Hematology and Oncology, The Swedish Childhood Cancer Foundation, NordForsk
- Responsible party
- Sponsor-investigator, Mats Heyman, Karolinska University Hospital
- Investigators
- Mats Heyman, M.D. PhD, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911128
- Sponsor's protocol ID
- ALLTogether1 pilot
- Status last verified
- Aug 2025
- First submitted
- 26 Mar 2019
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be entered into the study database. The data will be used to inform the coming main study regarding safety and overall outcomes of the master protocol. As such, these outcomes may be published in the context of a comparison with the ALLTogether1 protocol (the master protocol including experimental interventions, NCT 04307576, or compared with legacy protocols of the participating study-groups, The data of the pilot protocol will be shared according to the same principles as ALLTogether1 data.
Publications
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.
PubMed 28819280Schramm 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.
PubMed 29966458Mondelaers 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.
PubMed 28751566Vora 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.
PubMed 23395119Pieters 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.
PubMed 27269950Fermer J, van Bunningen H, Zhou O, Abrahamsson J, Borssen M, Donner I, Heyman M, Holmqvist AS, Valind A, Vogt H, Ranta S, Harila A. Early Toxicity in Childhood Acute Lymphoblastic Leukemia: A Comparison of NOPHO ALL2008 and ALLTogether Protocols in Sweden. Pediatr Blood Cancer. 2026 Feb;73(2):e32168. doi: 10.1002/pbc.32168. Epub 2025 Nov 20.
PubMed 41262029
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03911128
- Acronym / sponsor ID
- ALLTogether1 pilot
- Conditions
- Leukemia, Acute Lymphoblastic
- Keywords
- Leukemia, Acute Lymphoblastic, ALL, ALLTogether, Leukaemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mats HeymanUniversity, hospital or other
- Collaborators
- Nordic Society for Pediatric Hematology and Oncology, The Swedish Childhood Cancer Foundation, NordForsk
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with newly diagnosed ALL | – | Other: Observational |
Who may qualify
- Ages
- 0 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants 0-45 years with newly diagnosed acute lymphoblastic leukaemia. The protocol has no gender-bias. The total estimated recruitment in the pilot study is 500 participants.
Key inclusion criteria (8 listed)
- 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.
- Age 0 - < 46 years (one day before 46th birthday) at the time of diagnosis, with the exception of infants with KMT2A-r BCP ALL (see exclusion criteria below).
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational study - no intervention | Other | Participants with newly diagnosed ALL |
Primary outcome
Event-free survival (EFS) compared to historical controls
Time frame: 5 year
Overall survival (OS) compared to historical controls
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 28819280Toft 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.
- Background: PubMed 29966458Schramm 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.
- Background: PubMed 28751566Mondelaers 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.
- Background: PubMed 23395119Vora 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.
- Background: PubMed 27269950Pieters 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.
- Derived from this study: PubMed 41262029Fermer J, van Bunningen H, Zhou O, Abrahamsson J, Borssen M, Donner I, Heyman M, Holmqvist AS, Valind A, Vogt H, Ranta S, Harila A. Early Toxicity in Childhood Acute Lymphoblastic Leukemia: A Comparison of NOPHO ALL2008 and ALLTogether Protocols in Sweden. Pediatr Blood Cancer. 2026 Feb;73(2):e32168. doi: 10.1002/pbc.32168. Epub 2025 Nov 20.
- Individual participant dataSharing planned: Undecided. Individual participant data will be entered into the study database. The data will be used to inform the coming main study regarding safety and overall outcomes of the master protocol. As such, these outcomes may be published in the context of a comparison with the ALLTogether1 protocol (the master protocol including experimental interventions, NCT 04307576, or compared with legacy protocols of the participating study-groups, The data of the pilot protocol will be shared according to the same principles as ALLTogether1 data.
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Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mats Heyman, M.D. PhD study chair
Karolinska University Hospital
57 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Acute Lymphoblastic, run by Mats Heyman at 57 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Spain, Sweden, Finland, Norway, Denmark and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Central Office (+46812370000, alltogether.karolinska@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) compared to historical controls (time frame: 5 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911128, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.