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RECRUITING

NCT04307576

PHASE3

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

Sponsor: Mats Heyman

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

0 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

6430

Start Date

2020-07-13

Completion Date

2033-06

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Leukemia, Acute Lymphoblastic

Interventions

DRUG

Omitted Doxorubicin

Omission of IV Doxorubicin

DRUG

Omitted Vincristine+Dexamethasone pulses

Omission of Vincristine+Dexamethasone pulses

DRUG

Inotuzumab Ozogamicin+Standard Maintenance Therapy

Addition of IV Inotuzumab ozogamicin before Maintenance Therapy

DRUG

Imatinib

p.o. Imatinib

DRUG

6-tioguanine+Standard Maintenance Therapy

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

DRUG

Blinatumomab

IV Blinatumomab

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.

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (139)