RecruitingPhase 3NCT04307576

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)


Sponsor

Mats Heyman

Enrollment

6,430 participants

Start Date

Jul 13, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

ALLTogether 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 master 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 and interventional trials included in the study-design.


Eligibility

Min Age: 0 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying new treatment strategies for children, teenagers, and young adults (up to age 45) who have been newly diagnosed with acute lymphoblastic leukemia (ALL), a type of blood cancer. You may be eligible if: you are between newborn and 45 years old with a newly confirmed diagnosis of ALL from an accredited laboratory; and you are being treated at a participating center. You may NOT be eligible if: you are a newborn with a specific genetic type of leukemia (KMT2A-rearranged); you are over 45 years old at diagnosis; you have mature B-cell (Burkitt) leukemia; you have a prior cancer diagnosis; your leukemia has relapsed; you have Philadelphia chromosome-positive ALL; or you have already started chemotherapy or steroids. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOmitted Doxorubicin

Omission of IV Doxorubicin

DRUGOmitted Vincristine+Dexamethasone pulses

Omission of Vincristine+Dexamethasone pulses

DRUGInotuzumab Ozogamicin+Standard Maintenance Therapy

Addition of IV Inotuzumab ozogamicin before Maintenance Therapy

DRUGImatinib

p.o. Imatinib

DRUG6-tioguanine+Standard Maintenance Therapy

Addition of p.o. 6-tioguanine to Standard Maintenance Therapy

DRUGBlinatumomab

IV Blinatumomab


Locations(139)

L'hôpital Universitaire des enfants Reine Fabiola (Huderf)

Brussels, Belgium

Cliniques Universitaires Saint-Luc (UCL)

Brussels, Belgium

University Hospital Antwerp

Edegem, Belgium

University Hospital Ghent

Ghent, Belgium

University Hospital Leuven, Dept of Paediatrics

Leuven, Belgium

CHC MontLégia, Boulevard Patience et Beaujonc 2

Liège, Belgium

CHR de la Citadelle

Liège, Belgium

Aalborg University Hospital, Dept of Paediatrics

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Aarhus University Hospital, Child and Adolescent Health

Aarhus, Denmark

Rigshospitalet, Dept of Haematology

Copenhagen, Denmark

Rigshospitalet, Dept of Paediatrics

Copenhagen, Denmark

Odense University Hospital, Dept of Paediatrics

Odense, Denmark

North Estonia Medical Centre, Dept of Haematology

Tallinn, Estonia

Tallinn Children´s Hospital, Dept of Paediatrics

Tallinn, Estonia

Tartu University Hospital

Tartu, Estonia

Helsinki University Hospital, Dept of Haematology

Helsinki, Finland

Helsinki University Hospital, Dept of Paediatrics

Helsinki, Finland

Kuopio University Hospital, Dept of Haematology

Kuopio, Finland

Kuopio University Hospital, Dept of Paediatrics

Kuopio, Finland

Oulu University Hospital, Dept of Haematology, Dept of Medicine

Oulu, Finland

Oulu University Hospital, Dept of Paediatrics

Oulu, Finland

Tampere University Hospital, Dept of Haematology

Tampere, Finland

Tampere University Hospital, Dept of Paediatrics

Tampere, Finland

Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit

Turku, Finland

Turku University Hospital, Dept of Paediatrics

Turku, Finland

CHU Amiens Groupe Hospitalier Sud

Amiens, France

CHU Angers

Angers, France

CHRU Besançon

Besançon, France

CHU Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, France

CHRU Brest - Morvan

Brest, France

Centre Hospitalier Universitaire Caen

Caen, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHU Dijon Hôpital François Mitterrand

Dijon, France

CHU de Grenoble site Nord - Hôpital Albert Michallon

Grenoble, France

CHRU de Lille - Hôpital Jeanne de Flandre

Lille, France

Hôpital de la mère et de l'enfant

Limoges, France

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

Lyon, France

CHU de Marseille - Hôpital de la Timone

Marseille, France

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France

CHU Nantes-Hôpital enfant-adolescent

Nantes, France

CHU Nice - Hôpital l'Archet 2

Nice, France

CHU Paris Saint Louis

Paris, France

CHU Paris Armand Trousseau

Paris, France

CHU Paris - Hôpital Robert Debré

Paris, France

CHU Poitiers

Poitiers, France

CHU Reims-American Hospital

Reims, France

CHU Rennes - Hôpital sud

Rennes, France

CHU Rouen

Rouen, France

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

Saint-Denis, France

CHU Saint Etienne Hôpital Nord

Saint-Etienne, France

CHU Strasbourg -Hôpital de Hautepierre

Strasbourg, France

CHU Toulouse

Toulouse, France

CHRU Tours- Hôpital Clocheville

Tours, France

CHU de Nancy - Hôpital de Brabois Enfant

Vandœuvre-lès-Nancy, France

Evangelisches Klinikum Bethel

Bielefeld, Germany

Universitätsklinikum Bonn

Bonn, Germany

Klinikum Bremen Mitte

Bremen, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

HELIOS Klinikum Krefeld

Krefeld, Germany

Universitätsmedizin Mainz

Mainz, Germany

Landspitali University Hospital, Children's Hospital

Reykjavik, Iceland

Our Lady's Children's Hospital

Dublin, Ireland

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

Vilnius, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Princess Máxima Center for Pediatric Oncology

Utrecht, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Haukeland University Hospital, Dept of Haematology

Bergen, Norway

Haukeland University Hospital, Dept of Paediatrics

Bergen, Norway

Oslo University Hospital, Dept of Haematology

Oslo, Norway

Oslo University Hospital, Dept of paediatric haemato- and oncology

Oslo, Norway

Stavanger University Hospital, Dept of Haematology

Stavanger, Norway

University Hospital North Norway, Dept of Haematology

Tromsø, Norway

University Hospital of North Norway, Dept of Paediatrics

Tromsø, Norway

St. Olavs University Hospital, Dept of Paediatrics

Trondheim, Norway

St. Olavs University Hospital, Dept of Haematology

Trondheim, Norway

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

Coimbra, Portugal

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

Hospital Universitario De Cruces

Barakaldo, Spain

Hospital Universitari Vall D Hebron

Barcelona, Spain

Hospital Sant Joan De Deu Barcelona

Esplugues de Llobregat, Spain

Hospital Infantil Universitario Nino Jesus

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

University Hospital Son Espases

Palma de Mallorca, Spain

University Hospital Virgen Del Rocio S.L.

Seville, Spain

Hospital Universitario Y Politecnico La Fe

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Sahlgrenska University Hospital, Section for Haematology and coagulation

Gothenburg, Sweden

Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology

Gothenburg, Sweden

Linköping University Hospital, Dept of Haematology

Linköping, Sweden

Linköping University Hospital, Dept of Paediatrics

Linköping, Sweden

Skåne University Hospital, Dept of Haematology

Lund, Sweden

Skåne University Hospital, Dept of Paediatrics

Lund, Sweden

Örebro University Hospital, Section for Haematology

Örebro, Sweden

Karolinska University Hospital, Dept of Paediatric Oncology and Haematology

Stockholm, Sweden

Karolinska University Hospital, Patient area Haematology

Stockholm, Sweden

Norrland University Hospital, Dept of Haematology

Umeå, Sweden

Norrland University Hospital, Dept of Paediatrics

Umeå, Sweden

Uppsala University Hospital, Dept of Haematology

Uppsala, Sweden

Uppsala University Hospital, Dept of Paediatric Haematology and Oncology

Uppsala, Sweden

Aberdeen Royal Infirmary, Aberdeen

Aberdeen, United Kingdom

Royal Aberdeen Children's Hospital, Aberdeen

Aberdeen, United Kingdom

Royal Belfast Hospital for Sick Children, Belfast

Belfast, United Kingdom

Belfast City Hospital, Belfast

Belfast, United Kingdom

The Queen Elizabeth Hospital, Birmingham

Birmingham, United Kingdom

Birmingham Children's Hospital, Birmingham

Birmingham, United Kingdom

Bristol Royal Hospital for Children / Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Addenbrooke's Hospital, Cambridge

Cambridge, United Kingdom

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

Cardiff, United Kingdom

University Hospital of Wales, Cardiff

Cardiff, United Kingdom

Ninewells Hospital, Dundee

Dundee, United Kingdom

Western General Hospital, Edinburgh

Edinburgh, United Kingdom

Royal Hospital for Children and Young People, Edinburgh

Edinburgh, United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow

Glasgow, United Kingdom

Royal Hospital for Children, Glasgow

Glasgow, United Kingdom

Leeds General Infirmary, Leeds

Leeds, United Kingdom

Leeds St James University Hospital

Leeds, United Kingdom

Leicester Royal Infirmary, Leicester

Leicester, United Kingdom

Alder Hey Children's Hospital, Liverpool

Liverpool, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

University College London Hospital, London

London, United Kingdom

Great Ormond Street Hospital for Children, London

London, United Kingdom

King's College Hospital

London, United Kingdom

St. Bartholomews Hospital

London, United Kingdom

Royal Manchester Children's Hospital, Manchester

Manchester, United Kingdom

The Christie NHS Foundation Trust (PTC)

Manchester, United Kingdom

Freeman Hospital, Newcastle

Newcastle, United Kingdom

Royal Victoria Infirmary, Newcastle

Newcastle upon Tyne, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Nottingham Queen's Medical Centre

Nottingham, United Kingdom

Churchill Hospital, Oxford

Oxford, United Kingdom

John Radcliffe Hospital, Oxford

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Royal Hallamshire Hospital, Sheffield

Sheffield, United Kingdom

Sheffield Children's Hospital, Sheffield

Sheffield, United Kingdom

Southampton General Hospital, Southampton

Southampton, United Kingdom

Royal Stoke University Hospital, Stoke

Stoke, United Kingdom

Royal Marsden Hospital, Sutton

Sutton, United Kingdom

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