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Taking people in IcelandPhase 3

Tests several treatment options for newly diagnosed acute lymphoblastic leukaemia in young people

Tests different treatments for newly diagnosed acute lymphoblastic leukaemia in people aged 0 to 45.

Key facts

Who runs it
Mats Heyman
Where
Reykjavik, IcelandSee the siteAlso in 14 other countries, 122 sites
Registry title
A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
Status
Recruiting
Phase
Phase 3
People taking part
6,430 people, planned
Started
13 Jul 2020
Expected to end
Jun 2033
Type of study
Interventional, 10 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Omitted Doxorubicin
  • Omitted Vincristine+Dexamethasone pulses
  • Inotuzumab Ozogamicin+Standard Maintenance Therapy
  • Imatinib
  • 6-tioguanine+Standard Maintenance Therapy
  • Blinatumomab
Record updated
12 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young adults aged 0 to 45 with newly diagnosed acute lymphoblastic leukaemia (ALL), a blood cancer, who are treated at a taking-part centre.

Age
0 up to 45 years at diagnosis (before the 46th birthday). Babies under 365 days with KMT2A-rearranged B-cell ALL cannot join.
Sex
All sexes can join.
Disease stage
Newly diagnosed T-cell or B-cell precursor ALL, confirmed by an accredited laboratory. Patients with mature B-ALL or relapsed ALL cannot join.
Earlier treatment
Patients must not have had more than 10mg prednisolone/m2/day of steroids for over one week, or other chemotherapy, in the 4 weeks before diagnosis.
Biomarker or test result
Patients with Ph-positive ALL (t(9;22) or BCR::ABL) cannot join. Patients with IG::MYC and a BCL2/6 rearrangement cannot join.

Main reasons for not taking part

  • Babies under 365 days with KMT2A-rearranged B-cell ALL
  • Age over 45 years at diagnosis
  • A previous cancer, or relapse of ALL
  • Ph-positive ALL (t(9;22) or BCR::ABL)
  • Pregnant or breast-feeding women

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2/6 rearrangement
  • 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)
  • 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
  • Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN)
  • 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
  • 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
  • Relapse of ALL
  • 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
  • Women of childbearing potential who are pregnant at the time of diagnosis
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 0 and 45 years old?

Where in Iceland

Also in 14 other countries, 122 sites

  • LandspitaliReykjavik, IcelandTaking people

About the trial

What the trial wants to find out

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.

The 10 groups in the trial

  • R1 - SR standard armNo study treatment, for comparison

    Standard risk arm receiving standard treatment (Delayed Intensification including Doxorubicin).

  • R1 - SR experimental armTreatment being tested

    Standard risk arm, receiving Delayed Intensification without Doxorubicin IV 3 x 30 mg/m2/dose.

    Treatment: Omitted Doxorubicin

  • R2 - IR-low standard armNo study treatment, for comparison

    Standard treatment with Delayed Intensification including Doxorubicin and Maintenance including Vincristine+Dexamethasone pulses.

  • R2 - IR-low experimental arm ATreatment being tested

    Standard treatment with omission of Doxorubicin IV 3 x 30 mg/m2/dose in the Delayed Intensification phase.

    Treatment: Omitted Doxorubicin

  • R3 - IR-high standard armNo study treatment, for comparison

    Intermediate risk high arm receiving Standard Maintenance Therapy.

  • R3-InO - IR-high experimental armTreatment being tested

    Inotuzumab IV 0,5 mg/m2, given on days 253, 260, 267 and on days 274, 281, 288 before start of Standard Maintenance Therapy.

    Treatment: Inotuzumab Ozogamicin+Standard Maintenance Therapy

  • ABL-class fusions interventionTreatment being tested

    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.

    Treatment: Imatinib

  • R3-TEAM - IR-high experimental armTreatment being tested

    6-tioguanine p.o, 2,5-12,5 mg/m2, given daily in addition to Standard Maintenance Therapy.

    Treatment: 6-tioguanine+Standard Maintenance Therapy

  • ALLTogether1 DS Blinatumomab interventionTreatment being tested

    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.

    Treatment: Blinatumomab

  • R2 - IR-low experimental arm BTreatment being tested

    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.

    Treatment: Omitted Vincristine+Dexamethasone pulses

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests several treatment options for newly diagnosed acute lymphoblastic leukaemia in young peopleGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04307576, who can take part
Record updated
12 August 2026