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

April 29, 2026 updated by: Mats Heyman

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)

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.

Study Overview

Status

Recruiting

Conditions

Leukemia, Acute Lymphoblastic

Intervention / Treatment

Detailed Description

ALLTogether is a European clinical treatment study for acute lymphoblastic leukaemia (ALL) in infants, children and young adults. The aims are to improve survival and quality of survival. In young people, ALL has excellent outcome with an overall survival of about 92% in children and 75% in young adults. Infants with BCP-ALL and KMT2A-rearrangements have a worse outcome and are treated according to separate protocols, but infants with KMT2A-germline and T-cell ALL have acceptable outcome on standard ALL therapy. However, patients still die of disease - from relapse because of under-treatment and a large fraction of patients are also over-treated: All patients risk treatment-related death and some suffer long-term side-effects or secondary cancer. To show improvement with such good survival, large populations are needed.

Study groups from Sweden, Norway, Iceland, Denmark, Finland, Estonia and Lithuania (NOPHO), the UK (UKALL), the Netherlands (DCOG), Germany (COALL), Belgium (BSPHO), Portugal (SHOP), Ireland (PHOAI), and France (SFCE), have designed a common treatment protocol.

The study has a complex clinical trial design with sub-protocols (the randomisations / intervention) connected to a master protocol. The master protocol consists of well established therapy-elements and in its design typical for current ALL therapy. The master protocol therapy is in the study design considered as standard of care (SOC) therapy for infants, children and young adults with ALL.

The study structure is defined by a master protocol onto which randomised and interventional sub-protocols as well as sub-studies may be added, run and stop in a modular fashion.

The randomisations / intervention may identify therapy that is less toxic, but equally efficacious for sub-groups of patients and innovative therapy that may reduce relapses and death from ALL. In the master protocol, improved risk-stratification is likely to increase survival and reduce unnecessary toxicity and the introduction of therapeutic drug monitoring (TDM) of Asparaginase activity will make the use of Asparaginase more rational and efficient and may thus improve overall outcomes.

The investigators hypothesise that patients stratified to the standard-risk group are over-treated. Therefore, it will be tested if the treatment can be safely reduced. In the R1 randomisation, patients will be randomised to receiving the Delayed Intensification (DI) phase of therapy with or without the anthracycline Doxorubicin.

A similar hypothesis of over-treatment will also be tested in patients stratified to the intermediate risk-low group. In the R2 randomisation patients will be randomly assigned to either removal of Doxorubicin during the DI phase or removal of Vincristine and Dexamethasone pulses during the maintenance phase or to the control group, which will be treated with Doxorubicin in DI as well as Vincristine and Dexamethasone pulses during maintenance. Patients will only be randomised once.

Randomisation R1 and R2 are only considered for children since adults have worse outcome and very poor survival after relapse, but the risk-stratification is likely to reduce the number of high-risk cases also in the adult-group.

Patients stratified as intermediate risk-high (IR-high) are identified as having an increased risk of relapse and thus a less favourable prognosis than the standard- and intermediate risk-low groups, but a more favourable prognosis than the high risk patients. The majority of all relapses in childhood ALL is expected to occur in the IR-high group. Following a relapse, only approximately 40% of the children can be successfully treated again and for adults the corresponding figure is less than 20 %, so preventing relapses is very important. New treatment options that improves the antileukaemic efficacy and which have an improved safety profile are urgently needed.

For IR-high patients Randomisation 3 (R3) is available. In R3 patients will be randomised to receive either:

the first six weeks of maintenance treatment are replaced by two 3- week cycles of Inotuzumab ozogamicin (InO) - Besponsa®. This is followed by maintenance therapy similar to the standard arm.
the addition of low dose 6-tioguanine (6TG) as an addition to the standard maintenance therapy.
standard maintenance therapy.

Patients with ABL-class fusions in their leukaemic clone will, as a non-randomised experimental intervention, be treated with an addition of a tyrosine-kinase inhibitor during the induction phase (for patients <25 years) and from the consolidation phase (patients ≥25 years). This intervention may shift therapy for previously resistant cases to lower intensity treatment with the associated reduced morbidity and may also reduce the number of relapses in analogy with the results in Ph+ ALL. The reason for not performing a randomised comparison is the rarity of the aberration and also the diversity of ABL-class fusions, reducing statistical power for any comparison further. For this reason, the results of this intervention may be pooled with other study-groups trying similar approaches.

A new intervention is introduced for Down syndrome patients with CD19 positive ALL: ALLTogether1 DS (NRI2). For Down syndrome-ALL patients who have end of Induction MRD detectable but <25% two conventional chemotherapy consolidation blocks will be replaced with two blocks of Blinatumomab. Recruitment to this intervention was closed at the end of August 2024.

For high-risk B-lineage patients, CAR-T therapy can be an alternative to high-risk blocks and stem-cell transplant, but in this case the intervention (CAR-T infusion) will be performed outside the ALLTogether1 study. However, the stratification-system in ALLTogether1 will define the population with a potential CAR-T indication.

ALLTogether1 also includes five sub-studies:

Efficacy and pharmacokinetics of Imatinib in ABL-class fusion positive ALL

Target population: All ABL-class patients enrolled in the ALLTogether study. Biomaterials to be collected at diagnosis, during TKI treatment, follow-up and relapse.

Aims

To determine the efficacy and dosing target of imatinib in the treatment of ABL-class leukemia
To find the best discriminative biomarkers for TKI response in ABL-class ALL
To determine the frequency of intrinsic (at diagnosis) and acquired TKI resistance (due to treatment), including backtracking of mutations using imatinib PK/PD findings during treatment
To find causes of TKI resistance in ABL-class patients
To describe the pharmacokinetics of Imatinib in TKI-treated patients

Objectives

To determine the percent of ABL-class patients who need to switch from IR-high to HR because of high MRD levels
To determine the effect of imatinib exposure on clinical outcome, including pharmacokinetic measurements of imatinib
To determine the molecular response to imatinib by monitoring fusion gene levels and mutational spectrum at diagnosis and during follow up
To determine whether the molecular response parameters reflect the Ig/TCR MRD or flow-MRD response or are a better predictor of therapy failure than Ig/TCR or flow-based MRD monitoring
To determine the phosphorylation status of ABL-class proteins and presence of TKI-resistance associated mutations in ABL genes prior to imatinib treatment and the emergence of such mutations during treatment with imatinib
To determine the presence of mutations in regulatory /other genes before and during imatinib treatment and functionally address the importance of these mutations in TKI resistance
To determine whether the efficacy of TKIs depends on the type of fusion gene
To describe inter- and intraindividual variations in imatinib PK (=trough levels) during therapy of ABL-class ALL
To describe associations between PK of imatinib and end-of-induction MRD (<25 yrs only) and end-of-consolidation MRD (all patients)
To describe associations between imatinib PK and relapse rates (overall, bone-marrow and CNS), event-free survival as well as overall survival;
To describe associations between imatinib PK and toxicities (including e.g. height z-scores at diagnosis and end of therapy, pancreatitis, treatment delays) with focus on those toxicities that are routinely monitored in ALLTogether.

Biomarkers to Reform Approaches to therapy-Induced Neurotoxicity (BRAIN)

Target population: All patients registered on ALLTogether1 aged ≥ 4 years at end of therapy (Arm A) and all patients registered on ALLTogether1 aged 2-21 years at start of therapy (Arm B) and without:

Pre-existing neurodevelopmental delay (e.g Trisomy 21) prior to diagnosis of ALL
Significant visual or motor impairment preventing use of a computer/touch screen ipad

All centres are invited to enrol to arm A (Main BRAIN) of the study. Arm B (Longitudinal BRAIN) will be carried out in selected centres.

Aims

To implement universal screening of all children for adverse neurocognitive outcomes at the end of treatment using a validated user-friendly computer software programme (CogState) and compare neurocognitive outcomes by treatment allocation (Arm A).
To identify risk factors for adverse outcomes including whether acute neurotoxic events are associated with poor performance on cognitive tests at end of therapy compared to patients without acute neurotoxicity (Arm A).
To examine changes in neurocognitive performance over time and the risk/protective factors associated with differences in outcome, such as demographic, clinical, and physical/psychosocial factors (Arm B).

Primary end-point

a. Proportion of children with a z-score <1.5 on detection and/or identification CogState tasks in each treatment arm at the end of ALL therapy. A z-score < 1.5 correlates with moderate cognitive impairment at a level that may require additional support.

Secondary and exploratory end-points

Association between CogState scores at end of treatment and overt neurotoxic episodes as recorded on the trial adverse event database.
Association between Cogstate scores and clinical and demographic variables - age, sex, ethnicity, CNS status.
Proportion of children with scores <1.5SD for one card learning (learning), one back (working memory), Groton's maze (executive function), digit symbol substitution (processing speed) on different treatment arms.
Association between CogState scores and patient reported outcome measures/Quality of life measurements collected as part of the main ALLTogether1 trial.
Changes in neurocognitive scores over time, including CogState and BRIEF-2/BRIEF-A scores.
Association between neurocognitive scores over time and interactions with demographic variables (age, sex), clinical variables (treatment arm, neurotoxicity), social-emotional and physical functioning (SDQ, PedsQL 4.0 Generic; PedsQL 3.0 Fatigue), and family factors (MEES; PedsQL FIM).

Association between asparaginase activity levels and outcome

Target population: All patients included in the ALLTogether1 protocol are eligible for participation.

Primary aim

To study the association between asparaginase activity levels and outcome (MRD, relapse, survival)

Secondary aims

To evaluate the association between asparaginase activity levels and toxicities, such as pancreatitis, infections and deep venous thrombosis (DVT)
To evaluate the association between asparaginase activity levels and hepatotoxicity in a subset of patients

CSF-Flow

Target population: All patients included in the ALLTogether1 protocol are eligible for participation

Aims

To use cerebrospinal fluid (CSF) flow cytometry (FCM) to improve the accuracy of diagnostic tests for CNS leukaemia compared to conventional CSF cytology. An associated objective will be to develop a recommended protocol for CSF flow cytometry with external quality assessment to ensure uniformity of measurement across the ALLTogether consortium.
To investigate whether negative FCM identifies a group of children at very low risk of CNS relapse, suitable for testing de-escalation of CNS-directed therapy in future trials.
To investigate whether positive FCM can identify children at increased risk of CNS relapse and whether patients with persistent positivity (FCM positive at day 15 onwards) might benefit from studies testing escalated CNS-directed therapy or a switch to more intensive treatment arms.
To collect matching CSF supernatant for studies comparing CSF FCM with soluble biomarkers (e.g. metabolic, cell-free DNA, proteomic and microRNA).

Maintenance therapy pharmacokinetics/-dynamics study

Target population: All patients included in the ALLTogether1 protocol are eligible for participation. For IR-high patients participating in the randomised InO- and TEAM sub-protocols, the monitoring of 6-mercaptopurine (6MP)/Methotrexate (MTX) metabolites at three months intervals is mandatory.

Aims and specific objectives

To map pharmacokinetics of 6MP and MTX during maintenance therapy in all patients in the ALLTogether protocol.
To associate metabolite profiles with TPMT and NUDT15 variants, as routinely analysed in ALLTogether.
To explore the association of event-free survival with DNA-TG and other 6MP/MTX metabolites.
To explore the association between risk of second cancers with DNA-TG and other 6MP/MTX metabolites.
To explore the association of risk of invasive infections with DNA-TG and other 6MP/MTX metabolites.
To explore the association of risk of osteonecrosis with DNA-TG and other 6MP/MTX metabolites.
To explore the association of sinusoidal obstruction syndrome with DNA-TG and other 6MP/MTX metabolites.

Study Type

Interventional

Enrollment (Estimated)

6430

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Global Clinical Trial Manager ALLTogether1
Phone Number: +46 8 123 700 00
Email: alltogether.karolinska@regionstockholm.se

Study Locations

Belgium
- - Brussels, Belgium, 1020
    - Recruiting
    - L'hôpital Universitaire des enfants Reine Fabiola (Huderf)
    - Principal Investigator:
      
      Laurence Dedeken, M.D.
  - Brussels, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires Saint-Luc (UCL)
    - Principal Investigator:
      
      Maelle Deville, M.D.
  - Edegem, Belgium, 2650
    - Recruiting
    - University Hospital Antwerp
    - Principal Investigator:
      
      Toon van Genechten, M.D.
  - Ghent, Belgium, 9000
    - Recruiting
    - University Hospital Ghent
    - Principal Investigator:
      
      Veerle Mondelaers, M.D.
  - Leuven, Belgium, 3000
    - Recruiting
    - University Hospital Leuven, Dept of Paediatrics
    - Principal Investigator:
      
      Heidi Segers, M.D.
  - Liège, Belgium, 4000
    - Recruiting
    - CHR de la Citadelle
    - Principal Investigator:
      
      Marie-Françoise Dresse, M.D.
  - Liège, Belgium, 4000
    - Recruiting
    - CHC MontLégia, Boulevard Patience et Beaujonc 2
    - Principal Investigator:
      
      Christophe Chantrain, M.D.
Denmark
- - Aalborg, Denmark, 9000
    - Recruiting
    - Aalborg University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Christina Friis Jensen, M.D.
  - Aarhus, Denmark, 8000
    - Recruiting
    - Aarhus University Hospital
    - Principal Investigator:
      
      Ingolf Mølle, M.D.
  - Aarhus, Denmark, 8200
    - Recruiting
    - Aarhus University Hospital, Child and Adolescent Health
    - Principal Investigator:
      
      Birgitte Klug Albertsen, M.D.
  - Copenhagen, Denmark, 2100
    - Recruiting
    - Rigshospitalet, Dept of Haematology
    - Principal Investigator:
      
      Ulrik Malthe Overgaard, M.D.
  - Copenhagen, Denmark, 2100
    - Recruiting
    - Rigshospitalet, Dept of Paediatrics
    - Principal Investigator:
      
      Bodil Als-Nielsen, M.D.
  - Odense, Denmark, 5000
    - Recruiting
    - Odense University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Peder Skov Wehner, M.D.
Estonia
- - Tallinn, Estonia, 13419
    - Recruiting
    - North Estonia Medical Centre, Dept of Haematology
    - Principal Investigator:
      
      Katrin Palk, M.D.
  - Tallinn, Estonia, 13419
    - Recruiting
    - Tallinn Children´s Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Kristi Lepik, M.D.
  - Tartu, Estonia, 50406
    - Recruiting
    - Tartu University Hospital
    - Principal Investigator:
      
      Mari Punab, M.D.
Finland
- - Helsinki, Finland, 00029
    - Recruiting
    - Helsinki University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Antti Kyrönlahti, M.D.
  - Helsinki, Finland, 00029
    - Recruiting
    - Helsinki University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Ulla Wartiovaara-Kautto, M.D.
  - Kuopio, Finland, 70029
    - Recruiting
    - Kuopio University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Kaisa Vepsäläinen, M.D.
  - Kuopio, Finland, 70029
    - Recruiting
    - Kuopio University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Manna Miilunpohja, M.D.
  - Oulu, Finland, 90029
    - Recruiting
    - Oulu University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Riitta Niinimäki, M.D.
  - Oulu, Finland, 90029
    - Recruiting
    - Oulu University Hospital, Dept of Haematology, Dept of Medicine
    - Principal Investigator:
      
      Sakari Kakko, M.D.
  - Tampere, Finland, 33521
    - Recruiting
    - Tampere University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Olli Lohi, M.D.
  - Tampere, Finland, 33521
    - Recruiting
    - Tampere University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Johanna Rimpiläinen, M.D.
  - Turku, Finland, 20520
    - Recruiting
    - Turku University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Päivi Lähteenmäki, M.D.
  - Turku, Finland, 20520
    - Recruiting
    - Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit
    - Principal Investigator:
      
      Pia Ettala, M.D.
France
- - Amiens, France, 80054
    - Recruiting
    - CHU Amiens Groupe Hospitalier Sud
    - Principal Investigator:
      
      Camille Leglise, M.D.
  - Angers, France, 49033
    - Recruiting
    - CHU Angers
    - Principal Investigator:
      
      Mylène Duplan, M.D.
  - Besançon, France, 25030
    - Recruiting
    - CHRU Besançon
    - Principal Investigator:
      
      Pauline Simon, M.D.
  - Bordeaux, France, 33076
    - Recruiting
    - CHU Bordeaux - Groupe Hospitalier Pellegrin
    - Principal Investigator:
      
      Stéphane Ducassou, M.D.
  - Brest, France, 29609
    - Recruiting
    - CHRU Brest - Morvan
    - Principal Investigator:
      
      Liana Carausu, M.D.
  - Caen, France, 14033
    - Recruiting
    - Centre Hospitalier Universitaire Caen
    - Principal Investigator:
      
      Damien Bodet, M.D.
  - Clermont-Ferrand, France, 63000
    - Recruiting
    - Chu Clermont-Ferrand
    - Principal Investigator:
      
      Justyna Kanold, M.D.
  - Dijon, France, 21000
    - Recruiting
    - CHU Dijon Hôpital François Mitterrand
    - Principal Investigator:
      
      Claire Desplantes, M.D.
  - Grenoble, France, 38043
    - Recruiting
    - CHU de Grenoble site Nord - Hôpital Albert Michallon
    - Principal Investigator:
      
      Corine Armari Alla
  - Lille, France, 59037
    - Recruiting
    - CHRU de Lille - Hôpital Jeanne de Flandre
    - Principal Investigator:
      
      Wadih Abou Chahla, M.D.
  - Limoges, France, 87042
    - Recruiting
    - Hôpital de la mère et de l'enfant
    - Principal Investigator:
      
      Christophe Piguet, M.D.
  - Lyon, France, 69373
    - Recruiting
    - CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP
    - Principal Investigator:
      
      Carine Halfon-Domenech, M.D.
  - Marseille, France, 13385
    - Recruiting
    - CHU de Marseille - Hôpital de la Timone
    - Principal Investigator:
      
      Paul Saultier, M.D.
  - Montpellier, France, 34295
    - Recruiting
    - CHU de Montpellier - Hôpital Arnaud de Villeneuve
    - Principal Investigator:
      
      Stéphanie Haouy, M.D.
  - Nantes, France, 44093
    - Recruiting
    - CHU Nantes-Hôpital enfant-adolescent
    - Principal Investigator:
      
      Caroline Thomas, M.D.
  - Nice, France, 6200
    - Recruiting
    - CHU Nice - Hôpital l'Archet 2
    - Principal Investigator:
      
      Pierre-Simon Rohrlich, M.D.
  - Paris, France, 75019
    - Recruiting
    - CHU Paris - Hôpital Robert Debré
    - Principal Investigator:
      
      Marion Strullu, M.D.
  - Paris, France, 75010
    - Recruiting
    - CHU Paris Saint Louis
    - Principal Investigator:
      
      Nicolas Boissel, M.D.
  - Paris, France, 75012
    - Recruiting
    - CHU Paris Armand Trousseau
    - Principal Investigator:
      
      Arnaud Petit, M.D.
  - Poitiers, France, 86021
    - Recruiting
    - CHU Poitiers
    - Principal Investigator:
      
      Frédéric Millot
  - Reims, France, 51100
    - Recruiting
    - CHU Reims-American Hospital
    - Principal Investigator:
      
      Claire Pluchart, M.D.
  - Rennes, France, 35203
    - Recruiting
    - CHU Rennes - Hôpital Sud
    - Principal Investigator:
      
      Virginie Gandemer, M.D.
  - Rouen, France, 76031
    - Recruiting
    - CHU Rouen
    - Principal Investigator:
      
      Pascale Schneider, M.D.
  - Saint-Denis, France, 97400
    - Recruiting
    - CHU De La Réunion - Site Nord (Hôpital Félix GUYON)
    - Principal Investigator:
      
      Yves Reguerre, M.D.
  - Saint-Etienne, France, 42055
    - Recruiting
    - CHU Saint Etienne Hopital Nord
    - Principal Investigator:
      
      Sandrine Thouvenin-Doulet, M.D.
  - Strasbourg, France, 67098
    - Recruiting
    - CHU Strasbourg -Hôpital de Hautepierre
    - Principal Investigator:
      
      Catherine Paillard, M.D.
  - Toulouse, France, 31059
    - Recruiting
    - CHU Toulouse
    - Principal Investigator:
      
      Marlène Pasquet, M.D.
  - Tours, France, 37000
    - Recruiting
    - CHRU Tours- Hôpital Clocheville
    - Principal Investigator:
      
      Julien Lejeune, M.D.
  - Vandœuvre-lès-Nancy, France, 54511
    - Recruiting
    - CHU de Nancy - Hôpital de Brabois Enfant
    - Principal Investigator:
      
      Cécile Pochon, M.D.
Germany
- - Bielefeld, Germany, 33617
    - Recruiting
    - Evangelisches Klinikum Bethel
    - Principal Investigator:
      
      Norbert Jorch, M.D.
  - Bonn, Germany, 53113
    - Recruiting
    - Universitätsklinikum Bonn
    - Principal Investigator:
      
      Ina Hainmann
  - Bremen, Germany, 28177
    - Recruiting
    - Klinikum Bremen Mitte
    - Principal Investigator:
      
      Arnulf Pekrun, M.D.
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitatsklinikum Hamburg-Eppendorf
    - Principal Investigator:
      
      Gabriele Escherich, M.D.
  - Krefeld, Germany, 47805
    - Recruiting
    - Helios Klinikum Krefeld
    - Principal Investigator:
      
      Thomas Imschweiler, M.D.
  - Mainz, Germany, 55131
    - Recruiting
    - Universitätsmedizin Mainz
    - Principal Investigator:
      
      Jörg Faber, M.D.
Iceland
- - Reykjavik, Iceland, 101
    - Recruiting
    - Landspitali University Hospital, Children's Hospital
    - Principal Investigator:
      
      Gauti Rafn Vilbergsson, M.D.
Ireland
- - Dublin, Ireland
    - Recruiting
    - Our Lady's Children's Hospital
    - Principal Investigator:
      
      Owen Smith, M.D.
Lithuania
- - Vilnius, Lithuania, 08661
    - Recruiting
    - Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos
    - Principal Investigator:
      
      Goda Vaitkeviciene, M.D.
  - Vilnius, Lithuania, 08661
    - Not yet recruiting
    - Vilnius University Hospital Santaros Klinikos
    - Principal Investigator:
      
      Laimonas Griskevicius, M.D.
Netherlands
- - Utrecht, Netherlands
    - Recruiting
    - University Medical Center Utrecht
    - Principal Investigator:
      
      Lotte van der Wagen, M.D.
  - Utrecht, Netherlands, 3584
    - Recruiting
    - Princess Máxima Center for Pediatric Oncology
    - Principal Investigator:
      
      Inge van der Sluis, M.D.
Norway
- - Bergen, Norway, 5021
    - Recruiting
    - Haukeland University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Nessar Ahmad Azrakhsh, M.D.
  - Bergen, Norway, 5021
    - Recruiting
    - Haukeland University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Anita Andrejeva, M.D.
  - Oslo, Norway, 0372
    - Recruiting
    - Oslo University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Hilde Skuterud Wik, M.D.
  - Oslo, Norway, 0424
    - Recruiting
    - Oslo University Hospital, Dept of paediatric haemato- and oncology
    - Principal Investigator:
      
      Inga Maria Johannsdottir, M.D.
  - Stavanger, Norway, 4011
    - Recruiting
    - Stavanger University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Waleed Majeed Mohammed, M.D.
  - Tromsø, Norway, 9019
    - Recruiting
    - University Hospital North Norway, Dept of Haematology
    - Principal Investigator:
      
      Lars Horvei, M.D.
  - Tromsø, Norway, 9038
    - Recruiting
    - University Hospital of North Norway, Dept of Paediatrics
    - Principal Investigator:
      
      Simon Kranz, M.D.
  - Trondheim, Norway, 7006
    - Recruiting
    - St. Olavs University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Bendik Lund, M.D.
  - Trondheim, Norway, 7030
    - Recruiting
    - St. Olavs University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Petter Quist-Paulsen, M.D.
Portugal
- - Coimbra, Portugal, 3000-602
    - Not yet recruiting
    - Centro Hospitalar e Universitário de Coimbra, EPE - Hospital Pediátrico de Coimbra
    - Principal Investigator:
      
      Manuel Brito, M.D.
  - Lisbon, Portugal, 1099-023
    - Recruiting
    - Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
    - Principal Investigator:
      
      Joaquin Duarte, M.D.
  - Porto, Portugal, 4200-072
    - Recruiting
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
    - Principal Investigator:
      
      Vitor Costa, M.D.
Spain
- - Barakaldo, Spain
    - Not yet recruiting
    - Hospital Universitario de Cruces
    - Principal Investigator:
      
      Rosa Maria Adán, M.D.
  - Barcelona, Spain
    - Not yet recruiting
    - Hospital Universitari Vall d Hebron
    - Principal Investigator:
      
      Thais Murciano, M.D.
  - Esplugues de Llobregat, Spain
    - Not yet recruiting
    - Hospital Sant Joan de Deu Barcelona
    - Principal Investigator:
      
      Jose Luis Dapena, M.D.
  - Madrid, Spain
    - Not yet recruiting
    - Hospital Universitario La Paz
    - Principal Investigator:
      
      Berta González, M.D.
  - Madrid, Spain
    - Not yet recruiting
    - Hospital Infantil Universitario Nino Jesus
    - Principal Investigator:
      
      Blanca Herrero, M.D.
  - Palma de Mallorca, Spain
    - Not yet recruiting
    - University Hospital Son Espases
    - Principal Investigator:
      
      Elena García, M.D.
  - Seville, Spain
    - Not yet recruiting
    - University Hospital Virgen Del Rocio S.L.
    - Principal Investigator:
      
      Águeda Molinos, M.D.
  - Valencia, Spain
    - Not yet recruiting
    - Hospital Universitario y Politécnico La Fe
    - Principal Investigator:
      
      Carolina Fuentes, M.D.
  - Zaragoza, Spain
    - Not yet recruiting
    - Hospital Universitario Miguel Servet
    - Principal Investigator:
      
      Carmen Rodríguez-Vigil, M.D.
Sweden
- - Gothenburg, Sweden, 41345
    - Recruiting
    - Sahlgrenska University Hospital, Section for Haematology and coagulation
    - Principal Investigator:
      
      Stella Wei, M.D.
  - Gothenburg, Sweden, 41685
    - Recruiting
    - Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology
    - Principal Investigator:
      
      Jonatan Källström, M.D.
  - Linköping, Sweden, 58185
    - Recruiting
    - Linköping University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Thomas Erger, M.D.
  - Linköping, Sweden, 58185
    - Recruiting
    - Linköping University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Hartmut Vogt, M.D.
  - Lund, Sweden, 22185
    - Recruiting
    - Skåne University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Beata Tomaszewska-Toporska, M.D.
  - Lund, Sweden, 22185
    - Recruiting
    - Skåne University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Anders Castor, M.D.
  - Stockholm, Sweden, 17176
    - Recruiting
    - Karolinska University Hospital, Dept of Paediatric Oncology and Haematology
    - Principal Investigator:
      
      Johan Malmros, M.D.
  - Stockholm, Sweden, 17176
    - Recruiting
    - Karolinska University Hospital, Patient area Haematology
    - Principal Investigator:
      
      Joel Joelsson, M.D.
  - Umeå, Sweden, 90185
    - Recruiting
    - Norrland University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Antonio Izarra, M.D.
  - Umeå, Sweden, 90185
    - Recruiting
    - Norrland University Hospital, Dept of Paediatrics
    - Principal Investigator:
      
      Ulrika Norén Nyström, M.D.
  - Uppsala, Sweden, 75185
    - Recruiting
    - Uppsala University Hospital, Dept of Haematology
    - Principal Investigator:
      
      Helene Hallböök, M.D.
  - Uppsala, Sweden, 75185
    - Recruiting
    - Uppsala University Hospital, Dept of Paediatric Haematology and Oncology
    - Principal Investigator:
      
      Arja Harila-Saari, M.D.
  - Örebro, Sweden, 70185
    - Recruiting
    - Örebro University Hospital, Section for Haematology
    - Principal Investigator:
      
      Erik Ahlstrand, M.D.
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Not yet recruiting
    - Aberdeen Royal Infirmary, Aberdeen
    - Principal Investigator:
      
      Gordon Taylor, M.D.
  - Aberdeen, United Kingdom
    - Recruiting
    - Royal Aberdeen Children's Hospital, Aberdeen
    - Principal Investigator:
      
      Gordon Taylor, M.D.
  - Belfast, United Kingdom, BT12 6BA
    - Not yet recruiting
    - Royal Belfast Hospital for Sick Children, Belfast
    - Principal Investigator:
      
      Bethany Mitchell, M.D.
  - Belfast, United Kingdom, BT9 7AB
    - Not yet recruiting
    - Belfast City Hospital, Belfast
    - Principal Investigator:
      
      Nicholas Cunningham, M.D.
  - Birmingham, United Kingdom, B4 6NH
    - Recruiting
    - Birmingham Children's Hospital, Birmingham
    - Principal Investigator:
      
      Jayashree Motwani, M.D.
  - Birmingham, United Kingdom, B15 2TH
    - Recruiting
    - The Queen Elizabeth Hospital, Birmingham
    - Principal Investigator:
      
      Lindsay George, M.D.
  - Bristol, United Kingdom, BS2 8BJ
    - Recruiting
    - Bristol Royal Hospital for Children / Bristol Haematology and Oncology Centre
    - Principal Investigator:
      
      John Moppett, M.D.
    - Principal Investigator:
      
      Katharine Hodby, M.D.
  - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Addenbrooke's Hospital, Cambridge
    - Principal Investigator:
      
      Michael Gattens, M.D.
  - Cardiff, United Kingdom, CF14 4XW
    - Not yet recruiting
    - Noah's Ark Children's Hospital for Wales, Cardiff
    - Principal Investigator:
      
      M.D.
  - Cardiff, United Kingdom
    - Not yet recruiting
    - University Hospital of Wales, Cardiff
    - Principal Investigator:
      
      M.D.
  - Edinburgh, United Kingdom, EH9 1LF
    - Recruiting
    - Royal Hospital for Children and Young People, Edinburgh
    - Principal Investigator:
      
      Susan Baird, M.D.
  - Edinburgh, United Kingdom, EH2 2XU
    - Recruiting
    - Western General Hospital, Edinburgh
    - Principal Investigator:
      
      Neill Storrar, M.D.
  - Glasgow, United Kingdom, G12 0YN
    - Not yet recruiting
    - Beatson West of Scotland Cancer Centre, Glasgow
    - Principal Investigator:
      
      M.D.
  - Glasgow, United Kingdom, G51 4TF
    - Recruiting
    - Royal Hospital for Children, Glasgow
    - Principal Investigator:
      
      Sarah Clarke, M.D.
  - Leeds, United Kingdom, LS1 3EX
    - Recruiting
    - Leeds General Infirmary, Leeds
    - Principal Investigator:
      
      Danielle Ingham, M.D.
  - Leeds, United Kingdom, LS9 7TF
    - Recruiting
    - Leeds St James University Hospital
    - Principal Investigator:
      
      Richard Kelly, M.D.
  - Leicester, United Kingdom, LE1 5WW
    - Recruiting
    - Leicester Royal Infirmary, Leicester
    - Principal Investigator:
      
      Kaljit Bhuller, M.D.
  - Liverpool, United Kingdom
    - Recruiting
    - The Clatterbridge Cancer Centre NHS Foundation Trust
    - Principal Investigator:
      
      Arpad Toth, M.D.
  - Liverpool, United Kingdom, L12 2AP
    - Recruiting
    - Alder Hey Children's Hospital, Liverpool
    - Principal Investigator:
      
      Christopher Howell, M.D.
  - London, United Kingdom
    - Recruiting
    - King's College Hospital
    - Principal Investigator:
      
      Deborah Yallop, M.D.
  - London, United Kingdom, NW1 2BU
    - Recruiting
    - University College London Hospital, London
    - Principal Investigator:
      
      Rachael Hough, M.D.
  - London, United Kingdom, WC1N 3JH
    - Recruiting
    - Great Ormond Street Hospital for Children, London
    - Principal Investigator:
      
      Sujith Samarasinghe, M.D.
  - London, United Kingdom
    - Recruiting
    - St. Bartholomews Hospital
    - Principal Investigator:
      
      Bela Wrench, M.D.
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - The Christie NHS Foundation Trust (PTC)
    - Principal Investigator:
      
      Anna Castleton, M.D.
  - Manchester, United Kingdom, M13 9WL
    - Recruiting
    - Royal Manchester Children's Hospital, Manchester
    - Principal Investigator:
      
      Denise Bonney, M.D.
  - Newcastle, United Kingdom, NE7 7DN
    - Not yet recruiting
    - Freeman Hospital, Newcastle
    - Principal Investigator:
      
      M.D.
  - Newcastle upon Tyne, United Kingdom, NE1 4LP
    - Recruiting
    - Royal Victoria Infirmary, Newcastle
    - Principal Investigator:
      
      Geoff Shenton, M.D.
  - Nottingham, United Kingdom, NG5 1PB
    - Not yet recruiting
    - Nottingham City Hospital
    - Principal Investigator:
      
      Gerardo Errico, M.D.
  - Nottingham, United Kingdom, NG7 2UH
    - Recruiting
    - Nottingham Queen's Medical Centre
    - Principal Investigator:
      
      Simone Stockley, M.D.
  - Oxford, United Kingdom, OX3 7LE
    - Not yet recruiting
    - Churchill Hospital, Oxford
    - Principal Investigator:
      
      Andy Peniket, M.D.
  - Oxford, United Kingdom, OX3 9DU
    - Recruiting
    - John Radcliffe Hospital, Oxford
    - Principal Investigator:
      
      Amrana Qureshi, M.D.
  - Plymouth, United Kingdom
    - Recruiting
    - Derriford Hospital
    - Principal Investigator:
      
      Hannah Hunter, M.D.
  - Sheffield, United Kingdom, S10 2TH
    - Recruiting
    - Sheffield Children's Hospital, Sheffield
    - Principal Investigator:
      
      Jeanette Payne, M.D.
  - Sheffield, United Kingdom, S10 2JF
    - Recruiting
    - Royal Hallamshire Hospital, Sheffield
    - Principal Investigator:
      
      Nick Morley, M.D.
  - Southampton, United Kingdom, SO16 6YD
    - Recruiting
    - Southampton General Hospital, Southampton
    - Principal Investigator:
      
      Juliet Gray, M.D.
  - Stoke, United Kingdom, ST4 6QG
    - Not yet recruiting
    - Royal Stoke University Hospital, Stoke
    - Principal Investigator:
      
      M.D.
  - Sutton, United Kingdom, SM2 5PT
    - Recruiting
    - Royal Marsden Hospital, Sutton
    - Principal Investigator:
      
      Olya O'Connor, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 41 years (Child, Adult)

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: R1 - SR standard arm Standard risk arm receiving standard treatment (Delayed Intensification including Doxorubicin).
Experimental: R1 - SR experimental arm Standard risk arm, receiving Delayed Intensification without Doxorubicin IV 3 x 30 mg/m2/dose.	Drug: Omitted Doxorubicin Omission of IV Doxorubicin
No Intervention: R2 - IR-low standard arm Standard treatment with Delayed Intensification including Doxorubicin and Maintenance including Vincristine+Dexamethasone pulses.
Experimental: R2 - IR-low experimental arm A Standard treatment with omission of Doxorubicin IV 3 x 30 mg/m2/dose in the Delayed Intensification phase.	Drug: Omitted Doxorubicin Omission of IV Doxorubicin
No Intervention: R3 - IR-high standard arm Intermediate risk high arm receiving Standard Maintenance Therapy.
Experimental: R3-InO - IR-high experimental arm Inotuzumab IV 0,5 mg/m2, given on days 253, 260, 267 and on days 274, 281, 288 before start of Standard Maintenance Therapy.	Drug: Inotuzumab Ozogamicin+Standard Maintenance Therapy Addition of IV Inotuzumab ozogamicin before Maintenance Therapy Other Names: Besponsa+Maintenance Therapy
Experimental: ABL-class fusions intervention Imatinib 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.	Drug: Imatinib p.o. Imatinib
Experimental: R3-TEAM - IR-high experimental arm 6-tioguanine p.o, 2,5-12,5 mg/m2, given daily in addition to Standard Maintenance Therapy.	Drug: 6-tioguanine+Standard Maintenance Therapy Addition of p.o. 6-tioguanine to Standard Maintenance Therapy
Experimental: ALLTogether1 DS Blinatumomab intervention Blinatumomab 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.	Drug: Blinatumomab IV Blinatumomab Other Names: Blincyto
Experimental: R2 - IR-low experimental arm B Standard 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.	Drug: Omitted Vincristine+Dexamethasone pulses Omission of Vincristine+Dexamethasone pulses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival (EFS) for the whole protocol Time Frame: 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.	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 Time Frame: 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).	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 Time Frame: 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.	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 Time Frame: 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	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 Time Frame: End of first Blinatumomab infusion +/- 1 week	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 Outcome Measures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-mercaptopurine and Methotrexate metabolite pharmacokinetics (i.e. Ery-TGN/MeMP/MTXpg) for R3-TEAM Time Frame: From start of Maintenance therapy until the end of Maintenance therapy (protocol week 38 until protocol week 108)	Measurements of metabolites Ery-TGN/MeMP/MTXpg during Maintenance therapy.	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 Time Frame: From start of Maintenance therapy until the end of Maintenance therapy (protocol week 38 until protocol week 108)	Liver function parameters including hypoglycemia during Maintenance therapy	From start of Maintenance therapy until the end of Maintenance therapy (protocol week 38 until protocol week 108)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mats Heyman

Collaborators

Assistance Publique - Hôpitaux de Paris

Karolinska Institutet

Pfizer

The Swedish Research Council

Cancer Research UK

Danish Cancer Society

Amgen

The Novo Nordic Foundation

Servier

Danish Child Cancer Foundation

Belgium Health Care Knowledge Centre

Direction Générale de l'Offre de Soins

NordForsk

Swedish Cancer Society

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

Nova Laboratories Limited

The Swedish Childhood Cancer Foundation

Aamu Pediatric Cancer Foundation

Fundação Rui Osório de Castro

Acreditar - Associação de Pais e Amigos das Crianças com Cancro

Grupo Português De Leucemias Pediátricas

German Society for Pediatric Oncology and Hematology GPOH gGmbH

Investigators

Study Chair: Mats Heyman, MD, PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Estimated)

June 1, 2033

Study Completion (Estimated)

June 1, 2033

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ALLTogether1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

ALLTogether Data Sharing Policy FINAL VERSION 1.0 DATED 12APRIL2022 applies (full details available from Trial Central Office):

Policy

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.
All research papers should be open access whenever possible.
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.
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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Medical Conditions

Drug Interventions

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