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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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)

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia (NCT04307576) is a Phase 3 interventional studying Leukemia, Acute Lymphoblastic, sponsored by Mats Heyman. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Leukemia, Acute Lymphoblastic, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 6,430 participants makes this one of the larger Leukemia, Acute Lymphoblastic trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - willing to sign a consent form 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 Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Omitted Doxorubicin

Omission of IV Doxorubicin

DRUG

Omitted Vincristine+Dexamethasone pulses

Omission of Vincristine+Dexamethasone pulses

DRUG

Inotuzumab Ozogamicin+Standard Maintenance Therapy

Addition of IV Inotuzumab ozogamicin before Maintenance Therapy

DRUG

Imatinib

p.o. Imatinib

DRUG

6-tioguanine+Standard Maintenance Therapy

Addition of p.o. 6-tioguanine to Standard Maintenance Therapy

DRUG

Blinatumomab

IV Blinatumomab

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

L'hôpital Universitaire des enfants Reine Fabiola (Huderf)
Brussels, Belgium
Cliniques Universitaires Saint-Luc (UCL)
Brussels, Belgium
University Hospital Antwerp
Edegem, Belgium
University Hospital Ghent
Ghent, Belgium
University Hospital Leuven, Dept of Paediatrics
Leuven, Belgium
CHC MontLégia, Boulevard Patience et Beaujonc 2
Liège, Belgium
CHR de la Citadelle
Liège, Belgium
Aalborg University Hospital, Dept of Paediatrics
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Aarhus University Hospital, Child and Adolescent Health
Aarhus, Denmark
Rigshospitalet, Dept of Haematology
Copenhagen, Denmark
Rigshospitalet, Dept of Paediatrics
Copenhagen, Denmark
Odense University Hospital, Dept of Paediatrics
Odense, Denmark
North Estonia Medical Centre, Dept of Haematology
Tallinn, Estonia
Tallinn Children´s Hospital, Dept of Paediatrics
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Helsinki University Hospital, Dept of Haematology
Helsinki, Finland
Helsinki University Hospital, Dept of Paediatrics
Helsinki, Finland
Kuopio University Hospital, Dept of Haematology
Kuopio, Finland
Kuopio University Hospital, Dept of Paediatrics
Kuopio, Finland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04307576), the sponsor (Mats Heyman), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04307576 clinical trial studying?

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 full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04307576?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04307576?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04307576. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04307576. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.