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Massive new study aims to outsmart childhood leukemia

NCT ID NCT04307576

Disease control Sponsor: Mats Heyman Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study is testing a new, comprehensive treatment plan for children and young adults (ages 0-45) newly diagnosed with acute lymphoblastic leukemia (ALL). It combines the best approaches from previous successful treatments to improve survival and reduce side effects. The study will enroll over 6,400 participants across many hospitals. The goal is to see if this new plan works better than current standard treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 6,430 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Haematopoetic 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-rearranged (KMT2A-r) BCP ALL. * 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 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. * For each intervention/randomisation an additional set of inclusion-criteria is provided. Exclusion Criteria: * Age \< 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and/or a KMT2A fusion transcript). * 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::ABL 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. * Female patients, who are breast-feeding. * 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.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia leukemia lymphoblastic leukemia, acute, with lymphomatous features Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, acute lymphoblastic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    137 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aalborg University Hospital, Dept of Paediatrics

    RECRUITING

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8000, Denmark

  • Aarhus University Hospital, Child and Adolescent Health

    RECRUITING

    Aarhus, 8200, Denmark

  • Aberdeen Royal Infirmary, Aberdeen

    NOT_YET_RECRUITING

    Aberdeen, AB25 2ZN, United Kingdom

  • Addenbrooke's Hospital, Cambridge

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Alder Hey Children's Hospital, Liverpool

    RECRUITING

    Liverpool, L12 2AP, United Kingdom

  • Beatson West of Scotland Cancer Centre, Glasgow

    NOT_YET_RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Belfast City Hospital, Belfast

    NOT_YET_RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Birmingham Children's Hospital, Birmingham

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • Bristol Royal Hospital for Children / Bristol Haematology and Oncology Centre

    RECRUITING

    Bristol, BS2 8BJ, United Kingdom

  • CHC MontLégia, Boulevard Patience et Beaujonc 2

    RECRUITING

    Liège, 4000, Belgium

  • CHR de la Citadelle

    RECRUITING

    Liège, 4000, Belgium

  • CHRU Besançon

    RECRUITING

    Besançon, 25030, France

  • CHRU Brest - Morvan

    RECRUITING

    Brest, 29609, France

  • CHRU Tours- Hôpital Clocheville

    RECRUITING

    Tours, 37000, France

  • CHRU de Lille - Hôpital Jeanne de Flandre

    RECRUITING

    Lille, 59037, France

  • CHU Amiens Groupe Hospitalier Sud

    RECRUITING

    Amiens, 80054, France

  • CHU Angers

    RECRUITING

    Angers, 49033, France

  • CHU Bordeaux - Groupe Hospitalier Pellegrin

    RECRUITING

    Bordeaux, 33076, France

  • CHU Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63000, France

  • CHU De La Réunion - Site Nord (Hôpital Félix GUYON)

    RECRUITING

    Saint-Denis, 97400, France

  • CHU Dijon Hôpital François Mitterrand

    RECRUITING

    Dijon, 21000, France

  • CHU Nantes-Hôpital enfant-adolescent

    RECRUITING

    Nantes, 44093, France

  • CHU Nice - Hôpital l'Archet 2

    RECRUITING

    Nice, 6200, France

  • CHU Paris - Hôpital Robert Debré

    RECRUITING

    Paris, 75019, France

  • CHU Paris Armand Trousseau

    RECRUITING

    Paris, 75012, France

  • CHU Paris Saint Louis

    RECRUITING

    Paris, 75010, France

  • CHU Poitiers

    RECRUITING

    Poitiers, 86021, France

  • CHU Reims-American Hospital

    RECRUITING

    Reims, 51100, France

  • CHU Rennes - Hôpital sud

    RECRUITING

    Rennes, 35203, France

  • CHU Rouen

    RECRUITING

    Rouen, 76031, France

  • CHU Saint Etienne Hôpital Nord

    RECRUITING

    Saint-Etienne, 42055, France

  • CHU Strasbourg -Hôpital de Hautepierre

    RECRUITING

    Strasbourg, 67098, France

  • CHU Toulouse

    RECRUITING

    Toulouse, 31059, France

  • CHU de Grenoble site Nord - Hôpital Albert Michallon

    RECRUITING

    Grenoble, 38043, France

  • CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

    RECRUITING

    Lyon, 69373, France

  • CHU de Marseille - Hôpital de la Timone

    RECRUITING

    Marseille, 13385, France

  • CHU de Montpellier - Hôpital Arnaud de Villeneuve

    RECRUITING

    Montpellier, 34295, France

  • CHU de Nancy - Hôpital de Brabois Enfant

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Hospitalier Universitaire Caen

    RECRUITING

    Caen, 14033, France

  • Centro Hospitalar e Universitário de Coimbra, EPE - Hospital Pediátrico de Coimbra

    NOT_YET_RECRUITING

    Coimbra, 3000-602, Portugal

  • Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, 08661, Lithuania

  • Churchill Hospital, Oxford

    NOT_YET_RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Cliniques Universitaires Saint-Luc (UCL)

    RECRUITING

    Brussels, 1200, Belgium

  • Derriford Hospital

    RECRUITING

    Plymouth, United Kingdom

  • Evangelisches Klinikum Bethel

    RECRUITING

    Bielefeld, 33617, Germany

  • Freeman Hospital, Newcastle

    NOT_YET_RECRUITING

    Newcastle, NE7 7DN, United Kingdom

  • Great Ormond Street Hospital for Children, London

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • HELIOS Klinikum Krefeld

    RECRUITING

    Krefeld, 47805, Germany

  • Haukeland University Hospital, Dept of Haematology

    RECRUITING

    Bergen, 5021, Norway

  • Haukeland University Hospital, Dept of Paediatrics

    RECRUITING

    Bergen, 5021, Norway

  • Helsinki University Hospital, Dept of Haematology

    RECRUITING

    Helsinki, 00029, Finland

  • Helsinki University Hospital, Dept of Paediatrics

    RECRUITING

    Helsinki, 00029, Finland

  • Hospital Infantil Universitario Nino Jesus

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Sant Joan De Deu Barcelona

    RECRUITING

    Esplugues de Llobregat, Spain

  • Hospital Universitari Vall D Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario De Cruces

    NOT_YET_RECRUITING

    Barakaldo, Spain

  • Hospital Universitario La Paz

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitario Miguel Servet

    NOT_YET_RECRUITING

    Zaragoza, Spain

  • Hospital Universitario Y Politecnico La Fe

    NOT_YET_RECRUITING

    Valencia, Spain

  • Hôpital de la mère et de l'enfant

    RECRUITING

    Limoges, 87042, France

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

    RECRUITING

    Lisbon, 1099-023, Portugal

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    RECRUITING

    Porto, 4200-072, Portugal

  • John Radcliffe Hospital, Oxford

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Karolinska University Hospital, Dept of Paediatric Oncology and Haematology

    RECRUITING

    Stockholm, 17176, Sweden

  • Karolinska University Hospital, Patient area Haematology

    RECRUITING

    Stockholm, 17176, Sweden

  • King's College Hospital

    RECRUITING

    London, United Kingdom

  • Klinikum Bremen Mitte

    RECRUITING

    Bremen, 28177, Germany

  • Kuopio University Hospital, Dept of Haematology

    RECRUITING

    Kuopio, 70029, Finland

  • Kuopio University Hospital, Dept of Paediatrics

    RECRUITING

    Kuopio, 70029, Finland

  • L'hôpital Universitaire des enfants Reine Fabiola (Huderf)

    RECRUITING

    Brussels, 1020, Belgium

  • Landspitali University Hospital, Children's Hospital

    RECRUITING

    Reykjavik, 101, Iceland

  • Leeds General Infirmary, Leeds

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • Leeds St James University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Leicester Royal Infirmary, Leicester

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • Linköping University Hospital, Dept of Haematology

    RECRUITING

    Linköping, 58185, Sweden

  • Linköping University Hospital, Dept of Paediatrics

    RECRUITING

    Linköping, 58185, Sweden

  • Noah's Ark Children's Hospital for Wales, Cardiff

    NOT_YET_RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Norrland University Hospital, Dept of Haematology

    RECRUITING

    Umeå, 90185, Sweden

  • Norrland University Hospital, Dept of Paediatrics

    RECRUITING

    Umeå, 90185, Sweden

  • North Estonia Medical Centre, Dept of Haematology

    RECRUITING

    Tallinn, 13419, Estonia

  • Nottingham City Hospital

    NOT_YET_RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Nottingham Queen's Medical Centre

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • Odense University Hospital, Dept of Paediatrics

    RECRUITING

    Odense, 5000, Denmark

  • Oslo University Hospital, Dept of Haematology

    RECRUITING

    Oslo, 0372, Norway

  • Oslo University Hospital, Dept of paediatric haemato- and oncology

    RECRUITING

    Oslo, 0424, Norway

  • Oulu University Hospital, Dept of Haematology, Dept of Medicine

    RECRUITING

    Oulu, 90029, Finland

  • Oulu University Hospital, Dept of Paediatrics

    RECRUITING

    Oulu, 90029, Finland

  • Our Lady's Children's Hospital

    RECRUITING

    Dublin, Ireland

  • Princess Máxima Center for Pediatric Oncology

    RECRUITING

    Utrecht, 3584, Netherlands

  • Rigshospitalet, Dept of Haematology

    RECRUITING

    Copenhagen, 2100, Denmark

  • Rigshospitalet, Dept of Paediatrics

    RECRUITING

    Copenhagen, 2100, Denmark

  • Royal Aberdeen Children's Hospital, Aberdeen

    RECRUITING

    Aberdeen, United Kingdom

  • Royal Belfast Hospital for Sick Children, Belfast

    RECRUITING

    Belfast, BT12 6BA, United Kingdom

  • Royal Hallamshire Hospital, Sheffield

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

  • Royal Hospital for Children and Young People, Edinburgh

    RECRUITING

    Edinburgh, EH9 1LF, United Kingdom

  • Royal Hospital for Children, Glasgow

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Royal Manchester Children's Hospital, Manchester

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Royal Marsden Hospital, Sutton

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Royal Stoke University Hospital, Stoke

    NOT_YET_RECRUITING

    Stoke, ST4 6QG, United Kingdom

  • Royal Victoria Infirmary, Newcastle

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology

    RECRUITING

    Gothenburg, 41685, Sweden

  • Sahlgrenska University Hospital, Section for Haematology and coagulation

    RECRUITING

    Gothenburg, 41345, Sweden

  • Sheffield Children's Hospital, Sheffield

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Skåne University Hospital, Dept of Haematology

    RECRUITING

    Lund, 22185, Sweden

  • Skåne University Hospital, Dept of Paediatrics

    RECRUITING

    Lund, 22185, Sweden

  • Southampton General Hospital, Southampton

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • St. Bartholomews Hospital

    RECRUITING

    London, United Kingdom

  • St. Olavs University Hospital, Dept of Haematology

    RECRUITING

    Trondheim, 7030, Norway

  • St. Olavs University Hospital, Dept of Paediatrics

    RECRUITING

    Trondheim, 7006, Norway

  • Stavanger University Hospital, Dept of Haematology

    RECRUITING

    Stavanger, 4011, Norway

  • Tallinn Children´s Hospital, Dept of Paediatrics

    RECRUITING

    Tallinn, 13419, Estonia

  • Tampere University Hospital, Dept of Haematology

    RECRUITING

    Tampere, 33521, Finland

  • Tampere University Hospital, Dept of Paediatrics

    RECRUITING

    Tampere, 33521, Finland

  • Tartu University Hospital

    RECRUITING

    Tartu, 50406, Estonia

  • The Christie NHS Foundation Trust (PTC)

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    RECRUITING

    Liverpool, United Kingdom

  • The Queen Elizabeth Hospital, Birmingham

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit

    RECRUITING

    Turku, 20520, Finland

  • Turku University Hospital, Dept of Paediatrics

    RECRUITING

    Turku, 20520, Finland

  • University College London Hospital, London

    RECRUITING

    London, NW1 2BU, United Kingdom

  • University Hospital Antwerp

    RECRUITING

    Edegem, 2650, Belgium

  • University Hospital Ghent

    RECRUITING

    Ghent, 9000, Belgium

  • University Hospital Leuven, Dept of Paediatrics

    RECRUITING

    Leuven, 3000, Belgium

  • University Hospital North Norway, Dept of Haematology

    RECRUITING

    Tromsø, 9019, Norway

  • University Hospital Son Espases

    NOT_YET_RECRUITING

    Palma de Mallorca, Spain

  • University Hospital Virgen Del Rocio S.L.

    NOT_YET_RECRUITING

    Seville, Spain

  • University Hospital of North Norway, Dept of Paediatrics

    RECRUITING

    Tromsø, 9038, Norway

  • University Hospital of Wales, Cardiff

    NOT_YET_RECRUITING

    Cardiff, United Kingdom

  • University Medical Center Utrecht

    RECRUITING

    Utrecht, Netherlands

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, 53113, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsmedizin Mainz

    RECRUITING

    Mainz, 55131, Germany

  • Uppsala University Hospital, Dept of Haematology

    RECRUITING

    Uppsala, 75185, Sweden

  • Uppsala University Hospital, Dept of Paediatric Haematology and Oncology

    RECRUITING

    Uppsala, 75185, Sweden

  • Western General Hospital, Edinburgh

    RECRUITING

    Edinburgh, EH2 2XU, United Kingdom

  • Örebro University Hospital, Section for Haematology

    RECRUITING

    Örebro, 70185, Sweden

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