Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia.
N Toft, H Birgens, J Abrahamsson...
https://pubmed.ncbi.nlm.nih.gov/28819280Actively Recruiting
Phase 3
Age: 0Years - 45Years
All Genders
ID04307576
ALLTogether1 - Treatment Study Protocol for Children and Young Adults (0-45 Years) with Newly Diagnosed Acute Lymphoblastic Leukaemia
Led by Mats Heyman · Updated on 2026-05-05
6430
Participants Needed
138
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mats Heyman
Lead Sponsor
T
The Swedish Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment system called ALLTogether1 for infants, children, and young adults aged 0 to 45 years diagnosed with acute lymphoblastic leukaemia (ALL). This European study combines previous successful treatments from multiple groups to improve survival and quality of life. It addresses the challenge that some patients are over-treated while others relapse, aiming to find better risk-based treatment approaches and reduce side effects and relapse rates. The study uses a master protocol with established standard therapies and includes several randomized sub-studies to test different treatment modifications. These include reducing or omitting certain chemotherapy drugs, adding targeted therapies like Inotuzumab ozogamicin, Imatinib, 6-tioguanine, or Blinatumomab, and tailoring treatment for specific genetic subgroups. The study design allows adding or stopping sub-studies to find less toxic but effective therapies for various risk groups. Participants will undergo diagnosis confirmation and risk stratification, followed by assigned treatments according to their risk category and randomization group. Assessments include measuring event-free survival, disease relapse, molecular responses, and adverse effects over at least five years. Additional sub-studies collect biological samples and evaluate cognitive function, drug activity, and treatment toxicities. Safety and long-term outcomes are closely monitored throughout the study period.
CONDITIONS
Brief Title
A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
Who Can Participate
Age: 0Years - 45Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) confirmed by an accredited laboratory
- Age from 0 to less than 46 years at diagnosis except infants with KMT2A-rearranged BCP ALL
- Patients with surface immunoglobulin negative BCP-ALL and IG::MYC rearrangement unless concurrent BCL2/6 rearrangement
- Informed consent signed by patient and/or parents/legal guardians following local guidelines
- Diagnosis and treatment at a participating pediatric oncology or adult hematology center
- Resident or intending to settle in a participating country
- Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to treatment
- Additional inclusion criteria apply for each intervention or randomization
You will not qualify if you...
- Age under 365 days with KMT2A-rearranged BCP-ALL
- Age over 45 years at diagnosis
- Previous malignant diagnosis or relapse of ALL
- Patients with mature B-ALL or IG::MYC with concurrent BCL2/6 rearrangement
- Patients with Ph-positive ALL
- Known ALL prone syndromes except Down syndrome
- Treatment with systemic corticosteroids over 10mg prednisolone/m2/day for more than one week or other chemotherapy within 4 weeks before diagnosis
- Contraindications preventing adequate treatment
- Any condition interfering with study participation or compliance
- Pregnant or breastfeeding women of childbearing potential
- Fertile men or women unwilling to use adequate contraception during therapy
- Missing essential diagnostic data
- Additional exclusion criteria for each intervention or randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 106 weeks from diagnosis, depending on risk group and assigned treatment
Participants receive active treatment according to risk group-specific protocols that may include standard chemotherapy, randomised omission or addition of specific drugs such as Doxorubicin, Vincristine, Dexamethasone, Inotuzumab ozogamicin, Imatinib, 6-tioguanine, or Blinatumomab according to their subgroup and randomisation assignment.
Multiple visits throughout treatment phases including induction, consolidation, maintenance, and randomisation-specific interventions
Follow-up
Duration - At least 5 years after end of treatment
Participants are monitored for event-free survival, overall survival, relapse, treatment-related toxicities, and long-term side effects for at least 5 years after treatment completion.
Periodic follow-up visits during the 5-year post-treatment period
Trial Site Locations
Total: 138 locations
1
L'hôpital Universitaire des enfants Reine Fabiola (Huderf)
Brussels, Belgium, 1020
Actively Recruiting
2
Cliniques Universitaires Saint-Luc (UCL)
Brussels, Belgium, 1200
Actively Recruiting
3
University Hospital Antwerp
Edegem, Belgium, 2650
Actively Recruiting
4
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
5
University Hospital Leuven, Dept of Paediatrics
Leuven, Belgium, 3000
Actively Recruiting
6
CHC MontLégia, Boulevard Patience et Beaujonc 2
Liège, Belgium, 4000
Actively Recruiting
7
CHR de la Citadelle
Liège, Belgium, 4000
Actively Recruiting
8
Aalborg University Hospital, Dept of Paediatrics
Aalborg, Denmark, 9000
Actively Recruiting
9
Aarhus University Hospital
Aarhus, Denmark, 8000
Actively Recruiting
10
Aarhus University Hospital, Child and Adolescent Health
Aarhus, Denmark, 8200
Actively Recruiting
11
Rigshospitalet, Dept of Haematology
Copenhagen, Denmark, 2100
Actively Recruiting
12
Rigshospitalet, Dept of Paediatrics
Copenhagen, Denmark, 2100
Actively Recruiting
13
Odense University Hospital, Dept of Paediatrics
Odense, Denmark, 5000
Actively Recruiting
14
North Estonia Medical Centre, Dept of Haematology
Tallinn, Estonia, 13419
Actively Recruiting
15
Tallinn Children´s Hospital, Dept of Paediatrics
Tallinn, Estonia, 13419
Actively Recruiting
16
Tartu University Hospital
Tartu, Estonia, 50406
Actively Recruiting
17
Helsinki University Hospital, Dept of Haematology
Helsinki, Finland, 00029
Actively Recruiting
18
Helsinki University Hospital, Dept of Paediatrics
Helsinki, Finland, 00029
Actively Recruiting
19
Kuopio University Hospital, Dept of Haematology
Kuopio, Finland, 70029
Actively Recruiting
20
Kuopio University Hospital, Dept of Paediatrics
Kuopio, Finland, 70029
Actively Recruiting
21
Oulu University Hospital, Dept of Haematology, Dept of Medicine
Oulu, Finland, 90029
Actively Recruiting
22
Oulu University Hospital, Dept of Paediatrics
Oulu, Finland, 90029
Actively Recruiting
23
Tampere University Hospital, Dept of Haematology
Tampere, Finland, 33521
Actively Recruiting
24
Tampere University Hospital, Dept of Paediatrics
Tampere, Finland, 33521
Actively Recruiting
25
Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit
Turku, Finland, 20520
Actively Recruiting
26
Turku University Hospital, Dept of Paediatrics
Turku, Finland, 20520
Actively Recruiting
27
CHU Amiens Groupe Hospitalier Sud
Amiens, France, 80054
Actively Recruiting
28
CHU Angers
Angers, France, 49033
Actively Recruiting
29
CHRU Besançon
Besançon, France, 25030
Actively Recruiting
30
CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
Actively Recruiting
31
CHRU Brest - Morvan
Brest, France, 29609
Actively Recruiting
32
Centre Hospitalier Universitaire Caen
Caen, France, 14033
Actively Recruiting
33
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
Actively Recruiting
34
CHU Dijon Hôpital François Mitterrand
Dijon, France, 21000
Actively Recruiting
35
CHU de Grenoble site Nord - Hôpital Albert Michallon
Grenoble, France, 38043
Actively Recruiting
36
CHRU de Lille - Hôpital Jeanne de Flandre
Lille, France, 59037
Actively Recruiting
37
Hôpital de la mère et de l'enfant
Limoges, France, 87042
Actively Recruiting
38
CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
Lyon, France, 69373
Actively Recruiting
39
CHU de Marseille - Hôpital de la Timone
Marseille, France, 13385
Actively Recruiting
40
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Actively Recruiting
41
CHU Nantes-Hôpital enfant-adolescent
Nantes, France, 44093
Actively Recruiting
42
CHU Nice - Hôpital l'Archet 2
Nice, France, 6200
Actively Recruiting
43
CHU Paris Saint Louis
Paris, France, 75010
Actively Recruiting
44
CHU Paris Armand Trousseau
Paris, France, 75012
Actively Recruiting
45
CHU Paris - Hôpital Robert Debré
Paris, France, 75019
Actively Recruiting
46
CHU Poitiers
Poitiers, France, 86021
Actively Recruiting
47
CHU Reims-American Hospital
Reims, France, 51100
Actively Recruiting
48
CHU Rennes - Hôpital sud
Rennes, France, 35203
Actively Recruiting
49
CHU Rouen
Rouen, France, 76031
Actively Recruiting
50
CHU De La Réunion - Site Nord (Hôpital Félix GUYON)
Saint-Denis, France, 97400
Actively Recruiting
51
CHU Saint Etienne Hôpital Nord
Saint-Etienne, France, 42055
Actively Recruiting
52
CHU Strasbourg -Hôpital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
53
CHU Toulouse
Toulouse, France, 31059
Actively Recruiting
54
CHRU Tours- Hôpital Clocheville
Tours, France, 37000
Actively Recruiting
55
CHU de Nancy - Hôpital de Brabois Enfant
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
56
Evangelisches Klinikum Bethel
Bielefeld, Germany, 33617
Actively Recruiting
57
Universitätsklinikum Bonn
Bonn, Germany, 53113
Actively Recruiting
58
Klinikum Bremen Mitte
Bremen, Germany, 28177
Actively Recruiting
59
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
60
HELIOS Klinikum Krefeld
Krefeld, Germany, 47805
Actively Recruiting
61
Universitätsmedizin Mainz
Mainz, Germany, 55131
Actively Recruiting
62
Landspitali University Hospital, Children's Hospital
Reykjavik, Iceland, 101
Actively Recruiting
63
Our Lady's Children's Hospital
Dublin, Ireland
Actively Recruiting
64
Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania, 08661
Actively Recruiting
65
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania, 08661
Not Yet Recruiting
66
Princess Máxima Center for Pediatric Oncology
Utrecht, Netherlands, 3584
Actively Recruiting
67
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
68
Haukeland University Hospital, Dept of Haematology
Bergen, Norway, 5021
Actively Recruiting
69
Haukeland University Hospital, Dept of Paediatrics
Bergen, Norway, 5021
Actively Recruiting
70
Oslo University Hospital, Dept of Haematology
Oslo, Norway, 0372
Actively Recruiting
71
Oslo University Hospital, Dept of paediatric haemato- and oncology
Oslo, Norway, 0424
Actively Recruiting
72
Stavanger University Hospital, Dept of Haematology
Stavanger, Norway, 4011
Actively Recruiting
73
University Hospital North Norway, Dept of Haematology
Tromsø, Norway, 9019
Actively Recruiting
74
University Hospital of North Norway, Dept of Paediatrics
Tromsø, Norway, 9038
Actively Recruiting
75
St. Olavs University Hospital, Dept of Paediatrics
Trondheim, Norway, 7006
Actively Recruiting
76
St. Olavs University Hospital, Dept of Haematology
Trondheim, Norway, 7030
Actively Recruiting
77
Centro Hospitalar e Universitário de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, Portugal, 3000-602
Not Yet Recruiting
78
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, Portugal, 1099-023
Actively Recruiting
79
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Actively Recruiting
80
Hospital Universitario De Cruces
Barakaldo, Spain
Not Yet Recruiting
81
Hospital Universitari Vall D Hebron
Barcelona, Spain
Not Yet Recruiting
82
Hospital Sant Joan De Deu Barcelona
Esplugues de Llobregat, Spain
Not Yet Recruiting
83
Hospital Infantil Universitario Nino Jesus
Madrid, Spain
Not Yet Recruiting
84
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
85
University Hospital Son Espases
Palma de Mallorca, Spain
Not Yet Recruiting
86
University Hospital Virgen Del Rocio S.L.
Seville, Spain
Not Yet Recruiting
87
Hospital Universitario Y Politecnico La Fe
Valencia, Spain
Not Yet Recruiting
88
Hospital Universitario Miguel Servet
Zaragoza, Spain
Not Yet Recruiting
89
Sahlgrenska University Hospital, Section for Haematology and coagulation
Gothenburg, Sweden, 41345
Actively Recruiting
90
Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology
Gothenburg, Sweden, 41685
Actively Recruiting
91
Linköping University Hospital, Dept of Haematology
Linköping, Sweden, 58185
Actively Recruiting
92
Linköping University Hospital, Dept of Paediatrics
Linköping, Sweden, 58185
Actively Recruiting
93
Skåne University Hospital, Dept of Haematology
Lund, Sweden, 22185
Actively Recruiting
94
Skåne University Hospital, Dept of Paediatrics
Lund, Sweden, 22185
Actively Recruiting
95
Örebro University Hospital, Section for Haematology
Örebro, Sweden, 70185
Actively Recruiting
96
Karolinska University Hospital, Dept of Paediatric Oncology and Haematology
Stockholm, Sweden, 17176
Actively Recruiting
97
Karolinska University Hospital, Patient area Haematology
Stockholm, Sweden, 17176
Actively Recruiting
98
Norrland University Hospital, Dept of Haematology
Umeå, Sweden, 90185
Actively Recruiting
99
Norrland University Hospital, Dept of Paediatrics
Umeå, Sweden, 90185
Actively Recruiting
100
Uppsala University Hospital, Dept of Haematology
Uppsala, Sweden, 75185
Actively Recruiting
101
Uppsala University Hospital, Dept of Paediatric Haematology and Oncology
Uppsala, Sweden, 75185
Actively Recruiting
102
Aberdeen Royal Infirmary, Aberdeen
Aberdeen, United Kingdom, AB25 2ZN
Not Yet Recruiting
103
Royal Aberdeen Children's Hospital, Aberdeen
Aberdeen, United Kingdom
Actively Recruiting
104
Royal Belfast Hospital for Sick Children, Belfast
Belfast, United Kingdom, BT12 6BA
Not Yet Recruiting
105
Belfast City Hospital, Belfast
Belfast, United Kingdom, BT9 7AB
Not Yet Recruiting
106
The Queen Elizabeth Hospital, Birmingham
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
107
Birmingham Children's Hospital, Birmingham
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
108
Bristol Royal Hospital for Children / Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
109
Addenbrooke's Hospital, Cambridge
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
110
Noah's Ark Children's Hospital for Wales, Cardiff
Cardiff, United Kingdom, CF14 4XW
Not Yet Recruiting
111
University Hospital of Wales, Cardiff
Cardiff, United Kingdom
Not Yet Recruiting
112
Western General Hospital, Edinburgh
Edinburgh, United Kingdom, EH2 2XU
Actively Recruiting
113
Royal Hospital for Children and Young People, Edinburgh
Edinburgh, United Kingdom, EH9 1LF
Actively Recruiting
114
Beatson West of Scotland Cancer Centre, Glasgow
Glasgow, United Kingdom, G12 0YN
Not Yet Recruiting
115
Royal Hospital for Children, Glasgow
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
116
Leeds General Infirmary, Leeds
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
117
Leeds St James University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
118
Leicester Royal Infirmary, Leicester
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
119
Alder Hey Children's Hospital, Liverpool
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
120
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Actively Recruiting
121
University College London Hospital, London
London, United Kingdom, NW1 2BU
Actively Recruiting
122
Great Ormond Street Hospital for Children, London
London, United Kingdom, WC1N 3JH
Actively Recruiting
123
King's College Hospital
London, United Kingdom
Actively Recruiting
124
St. Bartholomews Hospital
London, United Kingdom
Actively Recruiting
125
Royal Manchester Children's Hospital, Manchester
Manchester, United Kingdom, M13 9WL
Actively Recruiting
126
The Christie NHS Foundation Trust (PTC)
Manchester, United Kingdom, M20 4BX
Actively Recruiting
127
Freeman Hospital, Newcastle
Newcastle, United Kingdom, NE7 7DN
Not Yet Recruiting
128
Royal Victoria Infirmary, Newcastle
Newcastle upon Tyne, United Kingdom, NE1 4LP
Actively Recruiting
129
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Not Yet Recruiting
130
Nottingham Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
131
Churchill Hospital, Oxford
Oxford, United Kingdom, OX3 7LE
Not Yet Recruiting
132
John Radcliffe Hospital, Oxford
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
133
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
134
Royal Hallamshire Hospital, Sheffield
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
135
Sheffield Children's Hospital, Sheffield
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
136
Southampton General Hospital, Southampton
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
137
Royal Stoke University Hospital, Stoke
Stoke, United Kingdom, ST4 6QG
Not Yet Recruiting
138
Royal Marsden Hospital, Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
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Research Team
G
Global Clinical Trial Manager ALLTogether1
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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