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)
1 other identifier
interventional
6,430
14 countries
135
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2020
Longer than P75 for phase_3
135 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedStudy Start
First participant enrolled
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2033
May 5, 2026
April 1, 2026
12.9 years
March 5, 2020
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Event-free survival (EFS) for the whole protocol
The primary endpoint for the whole protocol (compared with the legacy protocols of the participating study-groups forming the consortium) is event-free survival (EFS) - as defined in the protocol.
5 year estimates from the time of diagnosis will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up.
Event-free survival (EFS) for the TKI intervention
The primary endpoint for the TKI intervention is event-free survival (EFS) - as defined in the protocol, from the start of TKI until event or end of follow-up
From the start of TKI (day 15 or day 30), 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up for all interventions except Inotuzumab-randomisation (minimum 2-year follow-up).
Disease-free survival (DFS) R1 + R2
The primary endpoint for Randomisation 1 and 2 is disease-free survival (DFS) - as defined in the protocol counting from the time of randomisation
5 and 8 year estimates from the time of randomisation will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up.
Disease-free survival (DFS) R3
The primary endpoint for Randomisation 3 and the ABL-class fusion intervention is disease-free survival (DFS) - as defined in the protocol counting from the time of randomisation (R3) and the start of TKI-therapy (ABL-class fusion intervention).
5 year estimates from the time of randomisation will be measured but adequate follow-up for these estimates will be ensured: at least 2-year follow-up
MRD response after 1 cycle of Blinatumomab
Fraction of patients with undetectable MRD ("Complete MRD response") at the end of one cycle of Blinatumomab (+/- 1 week)
End of first Blinatumomab infusion +/- 1 week
Secondary Outcomes (47)
Overall survival (OS) for the whole protocol
5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up.
Overall survival (OS) for R1 + R2
5 and 8 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up.
Overall survival (OS) for R3
5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up
Overall survival (OS) for R3-TEAM associated with DNA-TG
5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 2 years follow-up
Overall survival (OS) for TKI
5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up (TKI).
- +42 more secondary outcomes
Other Outcomes (2)
6-mercaptopurine and Methotrexate metabolite pharmacokinetics (i.e. Ery-TGN/MeMP/MTXpg) for R3-TEAM
From start of Maintenance therapy until the end of Maintenance therapy (protocol week 38 until protocol week 108)
Abnormal liver function parameters (including hypoglycemia) for R3-TEAM
From start of Maintenance therapy until the end of Maintenance therapy (protocol week 38 until protocol week 108)
Study Arms (10)
R1 - SR standard arm
NO INTERVENTIONStandard risk arm receiving standard treatment (Delayed Intensification including Doxorubicin).
R1 - SR experimental arm
EXPERIMENTALStandard risk arm, receiving Delayed Intensification without Doxorubicin IV 3 x 30 mg/m2/dose.
R2 - IR-low standard arm
NO INTERVENTIONStandard treatment with Delayed Intensification including Doxorubicin and Maintenance including Vincristine+Dexamethasone pulses.
R2 - IR-low experimental arm A
EXPERIMENTALStandard treatment with omission of Doxorubicin IV 3 x 30 mg/m2/dose in the Delayed Intensification phase.
R3 - IR-high standard arm
NO INTERVENTIONIntermediate risk high arm receiving Standard Maintenance Therapy.
R3-InO - IR-high experimental arm
EXPERIMENTALInotuzumab IV 0,5 mg/m2, given on days 253, 260, 267 and on days 274, 281, 288 before start of Standard Maintenance Therapy.
ABL-class fusions intervention
EXPERIMENTALImatinib p.o. 340 mg/m2 given daily from day 15 or 30 (depending on age) to the end of therapy (week 106) in addition to Standard IR-high chemotherapy.
R3-TEAM - IR-high experimental arm
EXPERIMENTAL6-tioguanine p.o, 2,5-12,5 mg/m2, given daily in addition to Standard Maintenance Therapy.
ALLTogether1 DS Blinatumomab intervention
EXPERIMENTALBlinatumomab IV, 5 mcg/m2/day up to 28 mcg/day (detailed dosing in protocol) continous infusion. Two 28 day courses with a two week treatment free interval in between. Blinatumomab courses replace Consolidation 1 and Consolidation 2 in the standard protocol adapted for Down syndrome patients.
R2 - IR-low experimental arm B
EXPERIMENTALStandard treatment with omission of monthly pulses of Vincristine IV 1,5 mg/m2/dose and 5 days of Dexamethasone p.o. 6 mg/m2/day in the Maintenance Phase.
Interventions
Omission of IV Doxorubicin
Addition of p.o. 6-tioguanine to Standard Maintenance Therapy
Omission of Vincristine+Dexamethasone pulses
Addition of IV Inotuzumab ozogamicin before Maintenance Therapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mats Heymanlead
- The Swedish Research Councilcollaborator
- Pfizercollaborator
- The Swedish Childhood Cancer Foundationcollaborator
- Serviercollaborator
- NordForskcollaborator
- Aamu Pediatric Cancer Foundationcollaborator
- German Society for Pediatric Oncology and Hematology GPOH gGmbHcollaborator
- Clinical Trial Center North (CTC North GmbH & Co. KG)collaborator
- Belgium Health Care Knowledge Centrecollaborator
- Karolinska Institutetcollaborator
- Cancer Research UKcollaborator
- Fundação Rui Osório de Castrocollaborator
- Acreditar - Associação de Pais e Amigos das Crianças com Cancrocollaborator
- Grupo Português De Leucemias Pediátricascollaborator
- Amgencollaborator
- Nova Laboratories Limitedcollaborator
- Danish Child Cancer Foundationcollaborator
- Danish Cancer Societycollaborator
- The Novo Nordic Foundationcollaborator
- Assistance Publique - Hôpitaux de Pariscollaborator
- Direction Générale de l'Offre de Soinscollaborator
- Swedish Cancer Societycollaborator
Study Sites (138)
L'hôpital Universitaire des enfants Reine Fabiola (Huderf)
Brussels, 1020, Belgium
Cliniques Universitaires Saint-Luc (UCL)
Brussels, 1200, Belgium
University Hospital Antwerp
Edegem, 2650, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
University Hospital Leuven, Dept of Paediatrics
Leuven, 3000, Belgium
CHC MontLégia, Boulevard Patience et Beaujonc 2
Liège, 4000, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
Aalborg University Hospital, Dept of Paediatrics
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Aarhus University Hospital, Child and Adolescent Health
Aarhus, 8200, Denmark
Rigshospitalet, Dept of Haematology
Copenhagen, 2100, Denmark
Rigshospitalet, Dept of Paediatrics
Copenhagen, 2100, Denmark
Odense University Hospital, Dept of Paediatrics
Odense, 5000, Denmark
North Estonia Medical Centre, Dept of Haematology
Tallinn, 13419, Estonia
Tallinn Children´s Hospital, Dept of Paediatrics
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 50406, Estonia
Helsinki University Hospital, Dept of Haematology
Helsinki, 00029, Finland
Helsinki University Hospital, Dept of Paediatrics
Helsinki, 00029, Finland
Kuopio University Hospital, Dept of Haematology
Kuopio, 70029, Finland
Kuopio University Hospital, Dept of Paediatrics
Kuopio, 70029, Finland
Oulu University Hospital, Dept of Haematology, Dept of Medicine
Oulu, 90029, Finland
Oulu University Hospital, Dept of Paediatrics
Oulu, 90029, Finland
Tampere University Hospital, Dept of Haematology
Tampere, 33521, Finland
Tampere University Hospital, Dept of Paediatrics
Tampere, 33521, Finland
Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit
Turku, 20520, Finland
Turku University Hospital, Dept of Paediatrics
Turku, 20520, Finland
CHU Amiens Groupe Hospitalier Sud
Amiens, 80054, France
CHU Angers
Angers, 49033, France
CHRU Besançon
Besançon, 25030, France
CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
CHRU Brest - Morvan
Brest, 29609, France
Centre Hospitalier Universitaire Caen
Caen, 14033, France
CHU Clermont-Ferrand
Clermont-Ferrand, 63000, France
CHU Dijon Hôpital François Mitterrand
Dijon, 21000, France
CHU de Grenoble site Nord - Hôpital Albert Michallon
Grenoble, 38043, France
CHRU de Lille - Hôpital Jeanne de Flandre
Lille, 59037, France
Hôpital de la mère et de l'enfant
Limoges, 87042, France
CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
Lyon, 69373, France
CHU de Marseille - Hôpital de la Timone
Marseille, 13385, France
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295, France
CHU Nantes-Hôpital enfant-adolescent
Nantes, 44093, France
CHU Nice - Hôpital l'Archet 2
Nice, 6200, France
CHU Paris Saint Louis
Paris, 75010, France
CHU Paris Armand Trousseau
Paris, 75012, France
CHU Paris - Hôpital Robert Debré
Paris, 75019, France
CHU Poitiers
Poitiers, 86021, France
CHU Reims-American Hospital
Reims, 51100, France
CHU Rennes - Hôpital sud
Rennes, 35203, France
CHU Rouen
Rouen, 76031, France
CHU De La Réunion - Site Nord (Hôpital Félix GUYON)
Saint-Denis, 97400, France
CHU Saint Etienne Hôpital Nord
Saint-Etienne, 42055, France
CHU Strasbourg -Hôpital de Hautepierre
Strasbourg, 67098, France
CHU Toulouse
Toulouse, 31059, France
CHRU Tours- Hôpital Clocheville
Tours, 37000, France
CHU de Nancy - Hôpital de Brabois Enfant
Vandœuvre-lès-Nancy, 54511, France
Evangelisches Klinikum Bethel
Bielefeld, 33617, Germany
Universitätsklinikum Bonn
Bonn, 53113, Germany
Klinikum Bremen Mitte
Bremen, 28177, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
HELIOS Klinikum Krefeld
Krefeld, 47805, Germany
Universitätsmedizin Mainz
Mainz, 55131, Germany
Landspitali University Hospital, Children's Hospital
Reykjavik, 101, Iceland
Our Lady's Children's Hospital
Dublin, Ireland
Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
Vilnius, 08661, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661, Lithuania
Princess Máxima Center for Pediatric Oncology
Utrecht, 3584, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Haukeland University Hospital, Dept of Haematology
Bergen, 5021, Norway
Haukeland University Hospital, Dept of Paediatrics
Bergen, 5021, Norway
Oslo University Hospital, Dept of Haematology
Oslo, 0372, Norway
Oslo University Hospital, Dept of paediatric haemato- and oncology
Oslo, 0424, Norway
Stavanger University Hospital, Dept of Haematology
Stavanger, 4011, Norway
University Hospital North Norway, Dept of Haematology
Tromsø, 9019, Norway
University Hospital of North Norway, Dept of Paediatrics
Tromsø, 9038, Norway
St. Olavs University Hospital, Dept of Paediatrics
Trondheim, 7006, Norway
St. Olavs University Hospital, Dept of Haematology
Trondheim, 7030, Norway
Centro Hospitalar e Universitário de Coimbra, EPE - Hospital Pediátrico de Coimbra
Coimbra, 3000-602, Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, 1099-023, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, 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, 41345, Sweden
Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology
Gothenburg, 41685, Sweden
Linköping University Hospital, Dept of Haematology
Linköping, 58185, Sweden
Linköping University Hospital, Dept of Paediatrics
Linköping, 58185, Sweden
Skåne University Hospital, Dept of Haematology
Lund, 22185, Sweden
Skåne University Hospital, Dept of Paediatrics
Lund, 22185, Sweden
Örebro University Hospital, Section for Haematology
Örebro, 70185, Sweden
Karolinska University Hospital, Dept of Paediatric Oncology and Haematology
Stockholm, 17176, Sweden
Karolinska University Hospital, Patient area Haematology
Stockholm, 17176, Sweden
Norrland University Hospital, Dept of Haematology
Umeå, 90185, Sweden
Norrland University Hospital, Dept of Paediatrics
Umeå, 90185, Sweden
Uppsala University Hospital, Dept of Haematology
Uppsala, 75185, Sweden
Uppsala University Hospital, Dept of Paediatric Haematology and Oncology
Uppsala, 75185, Sweden
Aberdeen Royal Infirmary, Aberdeen
Aberdeen, AB25 2ZN, United Kingdom
Royal Aberdeen Children's Hospital, Aberdeen
Aberdeen, United Kingdom
Royal Belfast Hospital for Sick Children, Belfast
Belfast, BT12 6BA, United Kingdom
Belfast City Hospital, Belfast
Belfast, BT9 7AB, United Kingdom
The Queen Elizabeth Hospital, Birmingham
Birmingham, B15 2TH, United Kingdom
Birmingham Children's Hospital, Birmingham
Birmingham, B4 6NH, United Kingdom
Bristol Royal Hospital for Children / Bristol Haematology and Oncology Centre
Bristol, BS2 8BJ, United Kingdom
Addenbrooke's Hospital, Cambridge
Cambridge, CB2 0QQ, United Kingdom
Noah's Ark Children's Hospital for Wales, Cardiff
Cardiff, CF14 4XW, United Kingdom
University Hospital of Wales, Cardiff
Cardiff, United Kingdom
Western General Hospital, Edinburgh
Edinburgh, EH2 2XU, United Kingdom
Royal Hospital for Children and Young People, Edinburgh
Edinburgh, EH9 1LF, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow
Glasgow, G12 0YN, United Kingdom
Royal Hospital for Children, Glasgow
Glasgow, G51 4TF, United Kingdom
Leeds General Infirmary, Leeds
Leeds, LS1 3EX, United Kingdom
Leeds St James University Hospital
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary, Leicester
Leicester, LE1 5WW, United Kingdom
Alder Hey Children's Hospital, Liverpool
Liverpool, L12 2AP, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
University College London Hospital, London
London, NW1 2BU, United Kingdom
Great Ormond Street Hospital for Children, London
London, WC1N 3JH, United Kingdom
King's College Hospital
London, United Kingdom
St. Bartholomews Hospital
London, United Kingdom
Royal Manchester Children's Hospital, Manchester
Manchester, M13 9WL, United Kingdom
The Christie NHS Foundation Trust (PTC)
Manchester, M20 4BX, United Kingdom
Freeman Hospital, Newcastle
Newcastle, NE7 7DN, United Kingdom
Royal Victoria Infirmary, Newcastle
Newcastle upon Tyne, NE1 4LP, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Nottingham Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
Churchill Hospital, Oxford
Oxford, OX3 7LE, United Kingdom
John Radcliffe Hospital, Oxford
Oxford, OX3 9DU, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Hallamshire Hospital, Sheffield
Sheffield, S10 2JF, United Kingdom
Sheffield Children's Hospital, Sheffield
Sheffield, S10 2TH, United Kingdom
Southampton General Hospital, Southampton
Southampton, SO16 6YD, United Kingdom
Royal Stoke University Hospital, Stoke
Stoke, ST4 6QG, United Kingdom
Royal Marsden Hospital, Sutton
Sutton, SM2 5PT, United Kingdom
Related Publications (6)
Toft N, Birgens H, Abrahamsson J, Griskevicius L, Hallbook H, Heyman M, Klausen TW, Jonsson OG, Palk K, Pruunsild K, Quist-Paulsen P, Vaitkeviciene G, Vettenranta K, Asberg A, Frandsen TL, Marquart HV, Madsen HO, Noren-Nystrom U, Schmiegelow K. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia. Leukemia. 2018 Mar;32(3):606-615. doi: 10.1038/leu.2017.265. Epub 2017 Aug 18.
PMID: 28819280BACKGROUNDSchramm F, Zimmermann M, Jorch N, Pekrun A, Borkhardt A, Imschweiler T, Christiansen H, Faber J, Feuchtinger T, Schmid I, Beron G, Horstmann MA, Escherich G. Daunorubicin during delayed intensification decreases the incidence of infectious complications - a randomized comparison in trial CoALL 08-09. Leuk Lymphoma. 2019 Jan;60(1):60-68. doi: 10.1080/10428194.2018.1473575. Epub 2018 Jul 3.
PMID: 29966458BACKGROUNDMondelaers V, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Lutz P, Costa V, Sirvent N, Plouvier E, Munzer M, Poiree M, Minckes O, Millot F, Plantaz D, Maes P, Hoyoux C, Cave H, Rohrlich P, Bertrand Y, Benoit Y; Children-s Leukemia Group (CLG) of the European Organization for Research and Treatment of Cancer (EORTC). Prolonged versus standard native E. coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma: final results of the EORTC-CLG randomized phase III trial 58951. Haematologica. 2017 Oct;102(10):1727-1738. doi: 10.3324/haematol.2017.165845. Epub 2017 Jul 27.
PMID: 28751566BACKGROUNDVora A, Goulden N, Wade R, Mitchell C, Hancock J, Hough R, Rowntree C, Richards S. Treatment reduction for children and young adults with low-risk acute lymphoblastic leukaemia defined by minimal residual disease (UKALL 2003): a randomised controlled trial. Lancet Oncol. 2013 Mar;14(3):199-209. doi: 10.1016/S1470-2045(12)70600-9. Epub 2013 Feb 7.
PMID: 23395119BACKGROUNDPieters R, de Groot-Kruseman H, Van der Velden V, Fiocco M, van den Berg H, de Bont E, Egeler RM, Hoogerbrugge P, Kaspers G, Van der Schoot E, De Haas V, Van Dongen J. Successful Therapy Reduction and Intensification for Childhood Acute Lymphoblastic Leukemia Based on Minimal Residual Disease Monitoring: Study ALL10 From the Dutch Childhood Oncology Group. J Clin Oncol. 2016 Aug 1;34(22):2591-601. doi: 10.1200/JCO.2015.64.6364. Epub 2016 Jun 6.
PMID: 27269950BACKGROUNDToksvang LN, Als-Nielsen B, Bacon C, Bertasiute R, Duarte X, Escherich G, Helgadottir EA, Johannsdottir IR, Jonsson OG, Kozlowski P, Langenskjold C, Lepik K, Niinimaki R, Overgaard UM, Punab M, Raty R, Segers H, van der Sluis I, Smith OP, Strullu M, Vaitkeviciene G, Wik HS, Heyman M, Schmiegelow K. Thiopurine Enhanced ALL Maintenance (TEAM): study protocol for a randomized study to evaluate the improvement in disease-free survival by adding very low dose 6-thioguanine to 6-mercaptopurine/methotrexate-based maintenance therapy in pediatric and adult patients (0-45 years) with newly diagnosed B-cell precursor or T-cell acute lymphoblastic leukemia treated according to the intermediate risk-high group of the ALLTogether1 protocol. BMC Cancer. 2022 May 2;22(1):483. doi: 10.1186/s12885-022-09522-3.
PMID: 35501736DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mats Heyman, MD, PhD
Karolinska University Hospital
Central Study Contacts
Global Clinical Trial Manager ALLTogether1
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, Associate Professor
Study Record Dates
First Submitted
March 5, 2020
First Posted
March 13, 2020
Study Start
July 13, 2020
Primary Completion (Estimated)
June 1, 2033
Study Completion (Estimated)
June 1, 2033
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The ALLTogether Consortium will consider requests for individual participant data (IPD) that underlie published results after deidentification. Requests for access for unpublished data will also be considered on a case-by-case basis.
- Access Criteria
- Data access requests will be reviewed by The ALLTogether Board and, when applicable the ALLTogether Scientific committee. IPD will only be released if all personalised identifiers can be removed and for the sole use of the approved request (tertiary dissemination will not be permitted). Requestors will be required to sign a Data Access Agreement.
ALLTogether Data Sharing Policy FINAL VERSION 1.0 DATED 12APRIL2022 applies (full details available from Trial Central Office): Policy 1. The ALLTogether Consortium aims to maximise the availability of research data to the academic community for academic non-commercial research purposes with as few restrictions as possible. 2. All research papers should be open access whenever possible. 3. Clinical data: The ALLTogether Consortium will consider requests for individual participant data (IPD) that underlie published results after deidentification. Requests for access for unpublished data will also be considered on a case-by-case basis. 4. ALLTogether scientific data underpinning basic science/translational research papers should be made available to other researchers in the ALLTogether consortium and requests from academic researchers outside the consortium for access to scientific datasets should be addressed to the lead investigator of the ALLTogether study.