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Treatment for Acute Lymphoblastic Leukaemia in Young Patients

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)

PHASE3 · Karolinska University Hospital · NCT04307576

This study is testing a new way to treat young patients with acute lymphoblastic leukaemia to see if it can improve their chances of survival while reducing side effects.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment6430 (estimated)
Ages0 Years to 45 Years
SexAll
SponsorKarolinska University Hospital (other)
Drugs / interventionsInotuzumab, Blinatumomab, Imatinib, CAR-T, chemotherapy, Methotrexate, Doxorubicin
Locations138 sites (Brussels and 137 other locations)
Trial IDNCT04307576 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to improve treatment outcomes for infants, children, and young adults diagnosed with acute lymphoblastic leukaemia (ALL) by utilizing a master protocol that integrates successful treatment experiences from various European study groups. The study focuses on optimizing therapy to enhance survival rates while minimizing the risks of over-treatment and treatment-related complications. It includes a complex design with sub-protocols for randomized interventions, ensuring that patients receive the most effective and appropriate care based on their specific diagnosis. The trial is designed to gather data from a large population to demonstrate improvements in treatment efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 0 to 45 years newly diagnosed with T-lymphoblastic or B-lymphoblastic precursor leukaemia.

Not a fit: Patients with KMT2A-rearranged BCP ALL or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance survival rates and quality of life for young patients with acute lymphoblastic leukaemia.

How similar studies have performed: Previous studies have shown success with similar treatment approaches for acute lymphoblastic leukaemia, indicating a promising potential for this novel master protocol.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Brussels and 137 other locations

+88 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Leukemia, Acute Lymphoblastic, Leukemia, Acute Leukemia, ALL, ALLTogether, Leukaemia, Inotuzumab ozogamicin, Besponsa

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.