International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia

PHASE3RecruitingINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 31, 2031

Study Completion Date

December 31, 2032

Conditions
Acute Myeloid Leukaemia
Interventions
DRUG

Gemtuzumab ozogamicin

Antibody-conjugated chemotherapy agent.

DRUG

Liposomal daunorubicin

"Anthracycline~(Randomisation 1 (R1)) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug."

DRUG

Mitoxantrone

DNA-reactive agent

DRUG

Fludarabine

A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.

DRUG

Cytarabine

Pyrimidine nucleoside analogue, an antineoplastic agent.

DRUG

Busulfan

Alkylsulfonate

DRUG

Cyclophosphamide

A nitrogen mustard alkylating agent from the oxazaphosphorine group

Trial Locations (68)

Unknown

RECRUITING

Women and Children's Hospital Adelaide, Adelaide

RECRUITING

Queensland Children's Hospital, Brisbane

RECRUITING

Monash Children's Hospital, Melbourne

RECRUITING

Royal Childrens Hospital, Melbourne

RECRUITING

John Hunter Children's Hopsital, New Lambton Heights

RECRUITING

Perth Children's Hospital, Perth

RECRUITING

Sydney Children's Hospital, Sydney

RECRUITING

The Childrens Hospital At Westmead, Westmead

RECRUITING

Centre Hospitalier Universitaire Amiens - Picardie, Amiens

RECRUITING

Centre Hospitalier Universitaire D'angers, Angers

RECRUITING

Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz, Besançon

RECRUITING

Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin, Bordeaux

RECRUITING

Centre Hospitalier Regional Universitaire Brest - Hopital Morvan, Brest

RECRUITING

Centre Hospitalier Universitaire De Caen, Caen

RECRUITING

Centre Hospitalier Universitaire De Clermont-ferrand, Clermont-Ferrand

RECRUITING

Centre Hospitalier Universitaire Dijon Bourgogne - Hopital D'enfants, Dijon

RECRUITING

Centre Hospitalier Universitaire De Grenoble, Grenoble

RECRUITING

Hopital Jeanne Dr Flandre, Lille

RECRUITING

Centre Hospitalier Universitaire De Limoges, Limoges

RECRUITING

Centre Leon Berard, Lyon

RECRUITING

Hopital De La Timone, Marseille

RECRUITING

Centre Hospitalier Regional Universitaire Montpellier - Hopital Arnaud-de-villeneuve, Montpellier

RECRUITING

Centre Hospitalier Universitaire De Nancy, Nancy

RECRUITING

Centre Hospitalier Universitaire De Nantes, Nantes

RECRUITING

Centre Hospitalier Universitaire De NICE, Nice

RECRUITING

Hopital Armand Trousseau, Paris

RECRUITING

Hopital Robert Debre, Paris

RECRUITING

Hopital Saint Louis, Paris

RECRUITING

Centre Hospitalier Universitaire De Poitiers, Poitiers

RECRUITING

Chu De Reims, Reims

RECRUITING

Centre Hospitalier Universitaire De Rennes - Hopital Sud, Rennes

RECRUITING

Centre Hospitalier Universitaire De Rouen, Rouen

RECRUITING

Centre Hospitalier Universitaire Saint-etienne, Saint-Etienne

RECRUITING

Strasbourg Hautepierre, Strasbourg

RECRUITING

Centre Hospitalier Universitaire De Toulouse - Hopital Des Enfants, Toulouse

RECRUITING

Centre Hospitalier Regional Universitaire De Tours - Hopital Clocheville, Tours

RECRUITING

Our Lady's Hospital for Sick Children, Dublin

RECRUITING

Starship Childrens Hospital, Auckland

RECRUITING

Christchurch Hospital, Christchurch

RECRUITING

Kantonsspital Aarau, Aarau

RECRUITING

Universitäts-Kinderspital beider, Basel

RECRUITING

Ospedale San Giovanni, Bellinzona

RECRUITING

Inselspital Bern, Bern

RECRUITING

Hug Hopitaux Universitaires De Geneve, Geneva

RECRUITING

Centre Hospitalier Universitaire Vaudois Chuv Lausanne, Lausanne

RECRUITING

Luzerner Kantonspital - Kinderspital Luzern, Lucerne

RECRUITING

Ostschweizer Kinderspital, Sankt Gallen

RECRUITING

University Children's Hospital Zurich, Zurich

BT12 6BE

RECRUITING

Royal Belfast Hospital for Sick Children, Belfast

AB25 2ZG

RECRUITING

Royal Aberdeen Children's Hospital, Aberdeen

AB25 2ZN

RECRUITING

Aberdeen Royal Infirmary, NHS Grampian, Aberdeen

B4 6NH

RECRUITING

Birmingham Children's Hospital NHS Foundation Trust, Birmingham

BS1 3NU

RECRUITING

University Hospitals Bristol NHS Foundation Trust, Bristol

CB2 0QQ

RECRUITING

Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge

CF14 4XW

RECRUITING

Cardiff and Vale University Health Board, Noah's Ark Children's Hospital for Wales, Cardiff

EH9 1LF

RECRUITING

NHS Lothian, Royal Hospital for Sick Children, Edinburgh

G51 4TF

RECRUITING

NHS Greater Glasgow and Clyde, The Royal Hospital for Children, Glasgow

LS9 7TF

RECRUITING

Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds

L12 2AP

RECRUITING

Alder Hey Children's NHS Foundation Trust, Liverpool

NW1 2PG

RECRUITING

University College London Hospitals NHS Foundation Trust, London

SW3 6JJ

RECRUITING

The Royal Marsden NHS Foundation Trust, London

WC1N 3JH

RECRUITING

Great Ormond Street Hospital For Children NHS Trust, London

M13 9WL

RECRUITING

Royal Manchester Childrens' Hospital , Central Manchester University Hospitals NHS Foundation Trust, Manchester

NE7 7DN

RECRUITING

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle

NG7 2UH

RECRUITING

Nottingham University Hospitals NHS Trust, Nottingham

OX3 9DU

RECRUITING

John Radcliffe Hospital, Oxford Radcliffe Hospitals NHS Trust, Oxford

S10 2TH

RECRUITING

Sheffield Children's NHS Foundation Trust, Sheffield

SO16 6YD

RECRUITING

Southampton University Hospitals NHS Trust, Southampton

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

collaborator

Cancer Research UK

OTHER

collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Pfizer

INDUSTRY

lead

University of Birmingham

OTHER