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New pilot study aims to improve leukaemia treatment for young patients

NCT ID NCT03911128

Knowledge-focused Sponsor: Mats Heyman Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This pilot study is for children and young adults (0-45 years) newly diagnosed with acute lymphoblastic leukaemia (ALL). It collects information on standard treatments already used in clinics to help prepare for future research trials. The study involves 500 participants and focuses on improving diagnostics and data collection. No new drugs or treatments are being tested.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this pilot could pave the way for larger trials that may improve treatment strategies for acute lymphoblastic leukaemia.
What could go wrong
This is an observational pilot study, not testing new treatments. It only collects data on standard care, so direct benefits to participants are unlikely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants 0-45 years with newly diagnosed acute lymphoblastic leukaemia. The protocol has no gender-bias. The total estimated recruitment in the pilot study is 500 participants.

Ages

0 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Haematopoietic 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-r BCP ALL (see exclusion criteria below). * 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 and patients who intend to stay at least for the duration of the treatment 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. 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). These patients will be transferred to an appropriate trial for infant KMT2A-r BCP-ALL, if available. * 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::ABL1 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, see section 18.9. * Female patients, who are breast-feeding. * Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia leukemia lymphoblastic leukemia, acute, with lymphomatous features Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leukemia, acute lymphoblastic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aalborg University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    ACTIVE_NOT_RECRUITING

    Aarhus, 8000, Denmark

  • Aarhus University Hospital, Child and Adolescent Health

    ACTIVE_NOT_RECRUITING

    Aarhus, 8200, Denmark

  • Children's Hospital, Affiliate of Vilnius University Hospital

    ACTIVE_NOT_RECRUITING

    Vilnius, 08406, Lithuania

  • Haukeland University Hospital, Dept of Haematology

    ACTIVE_NOT_RECRUITING

    Bergen, 5021, Norway

  • Haukeland University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Bergen, 5021, Norway

  • Helsinki University Hospital, Dept of Haematology

    ACTIVE_NOT_RECRUITING

    Helsinki, 00029, Finland

  • Helsinki University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Helsinki, 00029, Finland

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, Spain

  • Hospital Clínico Universitario de Santiago

    RECRUITING

    Santiago de Compostela, Spain

  • Hospital Infantil Universitario Nino Jesus

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Dr.Balmis

    RECRUITING

    Alicante, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Fuencarral-El Pardo, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, Spain

  • Hospital Universitario Politécnico La Fe

    RECRUITING

    Valencia, Spain

  • Hospital Universitario San Joan de Déu

    ACTIVE_NOT_RECRUITING

    Barcelona, Spain

  • Hospital Universitario Son Espases

    RECRUITING

    Palma de Mallorca, Spain

  • Hospital Universitario Vall d'Hebron

    ACTIVE_NOT_RECRUITING

    Barcelona, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Barakaldo, Spain

  • Karolinska University Hospital, Dept of Paediatric Oncology and Haematology

    COMPLETED

    Stockholm, 17176, Sweden

  • Karolinska University Hospital, Patient area Haematology

    COMPLETED

    Stockholm, 17176, Sweden

  • Kuopio University Hospital, Dept of Haematology

    ACTIVE_NOT_RECRUITING

    Kuopio, 70029, Finland

  • Kuopio University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Kuopio, 70029, Finland

  • Landspitali University Hospital, Children's Hospital

    ACTIVE_NOT_RECRUITING

    Reykjavik, 101, Iceland

  • Linköping University Hospital, Dept of Haematology

    COMPLETED

    Linköping, 58185, Sweden

  • Linköping University Hospital, Dept of Paediatrics

    COMPLETED

    Linköping, 58185, Sweden

  • Norrland University Hospital, Dept of Haematology

    COMPLETED

    Umeå, 90185, Sweden

  • Norrland University Hospital, Dept of Paediatrics

    COMPLETED

    Umeå, 90185, Sweden

  • North Estonia Medical Centre, Dept of Haematology

    NOT_YET_RECRUITING

    Tallinn, 13419, Estonia

  • Odense University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Odense, 5000, Denmark

  • Oslo University Hospital, Dept of Haematology

    ACTIVE_NOT_RECRUITING

    Oslo, 0372, Norway

  • Oslo University Hospital, Dept of paediatric haemato- and oncology

    ACTIVE_NOT_RECRUITING

    Oslo, 0424, Norway

  • Oulu University Hospital, Dept of Haematology, Dept of Medicine

    NOT_YET_RECRUITING

    Oulu, 90029, Finland

  • Oulu University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Oulu, 90029, Finland

  • Rigshospitalet, Dept of Haematology

    ACTIVE_NOT_RECRUITING

    Copenhagen, 2100, Denmark

  • Rigshospitalet, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Copenhagen, 2100, Denmark

  • Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology

    COMPLETED

    Gothenburg, 41685, Sweden

  • Sahlgrenska University Hospital, Section for Haematology and coagulation

    COMPLETED

    Gothenburg, 41345, Sweden

  • Skåne University Hospital, Dept of Haematology

    COMPLETED

    Lund, 22185, Sweden

  • Skåne University Hospital, Dept of Paediatrics

    COMPLETED

    Lund, 22185, Sweden

  • St. Olavs University Hospital, Dept of Haematology

    ACTIVE_NOT_RECRUITING

    Trondheim, 7030, Norway

  • St. Olavs University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Trondheim, 7006, Norway

  • Stavanger University Hospital, Dept of Haematology

    ACTIVE_NOT_RECRUITING

    Stavanger, 4011, Norway

  • Tallinn Children´s Hospital, Dept of Paediatrics

    NOT_YET_RECRUITING

    Tallinn, 13419, Estonia

  • Tampere University Hospital, Dept of Haematology

    NOT_YET_RECRUITING

    Tampere, 33521, Finland

  • Tampere University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Tampere, 33521, Finland

  • Tartu University Hospital

    NOT_YET_RECRUITING

    Tartu, 50406, Estonia

  • Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit

    NOT_YET_RECRUITING

    Turku, 20520, Finland

  • Turku University Hospital, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Turku, 20520, Finland

  • University Hospital North Norway, Dept of Haematology

    ACTIVE_NOT_RECRUITING

    Tromsø, 9019, Norway

  • University Hospital of North Norway, Dept of Paediatrics

    ACTIVE_NOT_RECRUITING

    Tromsø, 9038, Norway

  • Uppsala University Hospital, Dept of Haematology

    COMPLETED

    Uppsala, 75185, Sweden

  • Uppsala University Hospital, Dept of Paediatric Haematology and Oncology

    COMPLETED

    Uppsala, 75185, Sweden

  • Vilnius University Hospital

    ACTIVE_NOT_RECRUITING

    Vilnius, 08661, Lithuania

  • Örebro University Hospital, Section for Haematology

    COMPLETED

    Örebro, 70185, Sweden

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