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

PHASE3RecruitingINTERVENTIONAL
Enrollment

6,430

Participants

Timeline

Start Date

July 13, 2020

Primary Completion Date

June 30, 2033

Study Completion Date

June 30, 2033

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

Trial Locations (130)

101

RECRUITING

Landspitali University Hospital, Children's Hospital, Reykjavik

1020

RECRUITING

L'hôpital Universitaire des enfants Reine Fabiola (Huderf), Brussels

1200

RECRUITING

Cliniques Universitaires Saint-Luc (UCL), Brussels

2100

RECRUITING

Rigshospitalet, Dept of Haematology, Copenhagen

RECRUITING

Rigshospitalet, Dept of Paediatrics, Copenhagen

2650

RECRUITING

University Hospital Antwerp, Edegem

3000

RECRUITING

University Hospital Leuven, Dept of Paediatrics, Leuven

3584

RECRUITING

Princess Máxima Center for Pediatric Oncology, Utrecht

4000

RECRUITING

CHC MontLégia, Boulevard Patience et Beaujonc 2, Liège

RECRUITING

CHR de la Citadelle, Liège

4011

RECRUITING

Stavanger University Hospital, Dept of Haematology, Stavanger

5000

RECRUITING

Odense University Hospital, Dept of Paediatrics, Odense

5021

RECRUITING

Haukeland University Hospital, Dept of Haematology, Bergen

RECRUITING

Haukeland University Hospital, Dept of Paediatrics, Bergen

6200

RECRUITING

CHU Nice - Hôpital l'Archet 2, Nice

7006

RECRUITING

St. Olavs University Hospital, Dept of Paediatrics, Trondheim

7030

RECRUITING

St. Olavs University Hospital, Dept of Haematology, Trondheim

8000

RECRUITING

Aarhus University Hospital, Aarhus

8200

RECRUITING

Aarhus University Hospital, Child and Adolescent Health, Aarhus

9000

RECRUITING

University Hospital Ghent, Ghent

RECRUITING

Aalborg University Hospital, Dept of Paediatrics, Aalborg

9019

RECRUITING

University Hospital North Norway, Dept of Haematology, Tromsø

9038

RECRUITING

University Hospital of North Norway, Dept of Paediatrics, Tromsø

13385

RECRUITING

CHU de Marseille - Hôpital de la Timone, Marseille

13419

RECRUITING

North Estonia Medical Centre, Dept of Haematology, Tallinn

RECRUITING

Tallinn Children´s Hospital, Dept of Paediatrics, Tallinn

14033

RECRUITING

Centre Hospitalier Universitaire Caen, Caen

17176

RECRUITING

Karolinska University Hospital, Dept of Paediatric Oncology and Haematology, Stockholm

RECRUITING

Karolinska University Hospital, Patient area Haematology, Stockholm

20246

RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Hamburg

20520

RECRUITING

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

RECRUITING

Turku University Hospital, Dept of Paediatrics, Turku

21000

RECRUITING

CHU Dijon Hôpital François Mitterrand, Dijon

22185

RECRUITING

Skåne University Hospital, Dept of Haematology, Lund

RECRUITING

Skåne University Hospital, Dept of Paediatrics, Lund

25030

RECRUITING

CHRU Besançon, Besançon

28177

RECRUITING

Klinikum Bremen Mitte, Bremen

29609

RECRUITING

CHRU Brest - Morvan, Brest

31059

RECRUITING

CHU Toulouse, Toulouse

33076

RECRUITING

CHU Bordeaux - Groupe Hospitalier Pellegrin, Bordeaux

33521

RECRUITING

Tampere University Hospital, Dept of Haematology, Tampere

RECRUITING

Tampere University Hospital, Dept of Paediatrics, Tampere

33617

RECRUITING

Evangelisches Klinikum Bethel, Bielefeld

34295

RECRUITING

CHU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier

35203

RECRUITING

CHU Rennes - Hôpital sud, Rennes

37000

RECRUITING

CHRU Tours- Hôpital Clocheville, Tours

38043

RECRUITING

CHU de Grenoble site Nord - Hôpital Albert Michallon, Grenoble

41345

RECRUITING

Sahlgrenska University Hospital, Section for Haematology and coagulation, Gothenburg

41685

RECRUITING

Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology, Gothenburg

42055

RECRUITING

CHU Saint Etienne Hôpital Nord, Saint-Etienne

44093

RECRUITING

CHU Nantes-Hôpital enfant-adolescent, Nantes

47805

RECRUITING

HELIOS Klinikum Krefeld, Krefeld

49033

RECRUITING

CHU Angers, Angers

50406

RECRUITING

Tartu University Hospital, Tartu

51100

RECRUITING

CHU Reims-American Hospital, Reims

53113

RECRUITING

Universitätsklinikum Bonn, Bonn

54511

RECRUITING

CHU de Nancy - Hôpital de Brabois Enfant, Vandœuvre-lès-Nancy

55131

RECRUITING

Universitätsmedizin Mainz, Mainz

58185

RECRUITING

Linköping University Hospital, Dept of Haematology, Linköping

RECRUITING

Linköping University Hospital, Dept of Paediatrics, Linköping

59037

RECRUITING

CHRU de Lille - Hôpital Jeanne de Flandre, Lille

63000

RECRUITING

CHU Clermont-Ferrand, Clermont-Ferrand

67098

RECRUITING

CHU Strasbourg -Hôpital de Hautepierre, Strasbourg

69373

RECRUITING

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

70029

RECRUITING

Kuopio University Hospital, Dept of Haematology, Kuopio

RECRUITING

Kuopio University Hospital, Dept of Paediatrics, Kuopio

70185

RECRUITING

Örebro University Hospital, Section for Haematology, Örebro

75010

RECRUITING

CHU Paris Saint Louis, Paris

75012

RECRUITING

CHU Paris Armand Trousseau, Paris

75019

RECRUITING

CHU Paris - Hôpital Robert Debré, Paris

75185

RECRUITING

Uppsala University Hospital, Dept of Haematology, Uppsala

RECRUITING

Uppsala University Hospital, Dept of Paediatric Haematology and Oncology, Uppsala

76031

RECRUITING

CHU Rouen, Rouen

80054

RECRUITING

CHU Amiens Groupe Hospitalier Sud, Amiens

86021

RECRUITING

CHU Poitiers, Poitiers

87042

RECRUITING

Hôpital de la mère et de l'enfant, Limoges

90029

RECRUITING

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

RECRUITING

Oulu University Hospital, Dept of Paediatrics, Oulu

90185

RECRUITING

Norrland University Hospital, Dept of Haematology, Umeå

RECRUITING

Norrland University Hospital, Dept of Paediatrics, Umeå

97400

RECRUITING

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

00029

RECRUITING

Helsinki University Hospital, Dept of Haematology, Helsinki

RECRUITING

Helsinki University Hospital, Dept of Paediatrics, Helsinki

Unknown

RECRUITING

Our Lady's Children's Hospital, Dublin

RECRUITING

University Medical Center Utrecht, Utrecht

RECRUITING

Royal Aberdeen Children's Hospital, Aberdeen, Aberdeen

NOT_YET_RECRUITING

University Hospital of Wales, Cardiff, Cardiff

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

RECRUITING

King's College Hospital, London

RECRUITING

St. Bartholomews Hospital, London

RECRUITING

Derriford Hospital, Plymouth

08661

RECRUITING

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

NOT_YET_RECRUITING

Vilnius University Hospital Santaros Klinikos, Vilnius

0372

RECRUITING

Oslo University Hospital, Dept of Haematology, Oslo

0424

RECRUITING

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

3000-602

NOT_YET_RECRUITING

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

1099-023

RECRUITING

Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Lisbon

4200-072

RECRUITING

Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto

AB25 2ZN

NOT_YET_RECRUITING

Aberdeen Royal Infirmary, Aberdeen, Aberdeen

BT12 6BA

NOT_YET_RECRUITING

Royal Belfast Hospital for Sick Children, Belfast, Belfast

BT9 7AB

NOT_YET_RECRUITING

Belfast City Hospital, Belfast, Belfast

B15 2TH

RECRUITING

The Queen Elizabeth Hospital, Birmingham, Birmingham

B4 6NH

RECRUITING

Birmingham Children's Hospital, Birmingham, Birmingham

BS2 8BJ

RECRUITING

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

CB2 0QQ

RECRUITING

Addenbrooke's Hospital, Cambridge, Cambridge

CF14 4XW

NOT_YET_RECRUITING

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

DD1 9SY

NOT_YET_RECRUITING

Ninewells Hospital, Dundee, Dundee

EH2 2XU

NOT_YET_RECRUITING

Western General Hospital, Edinburgh, Edinburgh

EH9 1LF

RECRUITING

Royal Hospital for Children and Young People, Edinburgh, Edinburgh

G12 0YN

NOT_YET_RECRUITING

Beatson West of Scotland Cancer Centre, Glasgow, Glasgow

G51 4TF

RECRUITING

Royal Hospital for Children, Glasgow, Glasgow

LS1 3EX

RECRUITING

Leeds General Infirmary, Leeds, Leeds

LS9 7TF

RECRUITING

Leeds St James University Hospital, Leeds

LE1 5WW

RECRUITING

Leicester Royal Infirmary, Leicester, Leicester

L12 2AP

RECRUITING

Alder Hey Children's Hospital, Liverpool, Liverpool

NW1 2BU

RECRUITING

University College London Hospital, London, London

WC1N 3JH

RECRUITING

Great Ormond Street Hospital for Children, London, London

M13 9WL

RECRUITING

Royal Manchester Children's Hospital, Manchester, Manchester

M20 4BX

RECRUITING

The Christie NHS Foundation Trust (PTC), Manchester

NE7 7DN

NOT_YET_RECRUITING

Freeman Hospital, Newcastle, Newcastle

NE1 4LP

RECRUITING

Royal Victoria Infirmary, Newcastle, Newcastle upon Tyne

NG5 1PB

NOT_YET_RECRUITING

Nottingham City Hospital, Nottingham

NG7 2UH

RECRUITING

Nottingham Queen's Medical Centre, Nottingham

OX3 7LE

NOT_YET_RECRUITING

Churchill Hospital, Oxford, Oxford

OX3 9DU

RECRUITING

John Radcliffe Hospital, Oxford, Oxford

S10 2JF

RECRUITING

Royal Hallamshire Hospital, Sheffield, Sheffield

S10 2TH

RECRUITING

Sheffield Children's Hospital, Sheffield, Sheffield

SO16 6YD

RECRUITING

Southampton General Hospital, Southampton, Southampton

ST4 6QG

NOT_YET_RECRUITING

Royal Stoke University Hospital, Stoke, Stoke

SM2 5PT

RECRUITING

Royal Marsden Hospital, Sutton, Sutton

All Listed Sponsors
collaborator

The Swedish Research Council

OTHER_GOV

collaborator

The Swedish Childhood Cancer Foundation

UNKNOWN

collaborator

Pfizer

INDUSTRY

collaborator

Servier

INDUSTRY

collaborator

NordForsk

UNKNOWN

collaborator

Aamu Pediatric Cancer Foundation

UNKNOWN

collaborator

German Society for Pediatric Oncology and Hematology GPOH gGmbH

OTHER

collaborator

Clinical Trial Center North (CTC North GmbH & Co. KG)

OTHER

collaborator

Belgium Health Care Knowledge Centre

OTHER_GOV

collaborator

Karolinska Institutet

OTHER

collaborator

Cancer Research UK

OTHER

collaborator

Fundação Rui Osório de Castro

UNKNOWN

collaborator

Acreditar - Associação de Pais e Amigos das Crianças com Cancro

UNKNOWN

collaborator

Grupo Português De Leucemias Pediátricas

UNKNOWN

collaborator

Amgen

INDUSTRY

collaborator

Nova Laboratories Limited

INDUSTRY

collaborator

Danish Child Cancer Foundation

OTHER

collaborator

Danish Cancer Society

OTHER

collaborator

The Novo Nordic Foundation

OTHER

collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

collaborator

Direction Générale de l'Offre de Soins

OTHER_GOV

collaborator

Swedish Cancer Society

OTHER

lead

Mats Heyman

OTHER

NCT04307576 - A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia | Biotech Hunter | Biotech Hunter