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Treatment protocol for young patients with acute lymphoblastic leukemia

A Treatment Study Protocol of the ALLTogether Consortium for Infants, Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL): a Pilot Study

Observational Karolinska University Hospital · NCT03911128

This study is trying to find the best ways to treat young patients with acute lymphoblastic leukemia by learning from successful treatments to improve their care and survival rates.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages0 Years to 45 Years
SexAll
SponsorKarolinska University Hospital Academic / other
Drugs / interventionsCAR-T, Chimeric Antigen Receptor
Locations53 sites (Aalborg and 52 other locations)
Trial IDNCT03911128 on ClinicalTrials.gov

What this trial studies

This observational pilot study aims to gather experiences from successful treatments of acute lymphoblastic leukemia (ALL) in infants, children, and young adults, creating a comprehensive platform for stratification and treatment. It involves collaboration among multiple study groups across several countries to optimize diagnostics and treatment protocols. The study focuses on standard care treatments and aims to improve survival rates while minimizing over-treatment and its associated risks. By utilizing a personalized risk-stratification algorithm, the study seeks to enhance the quality of care for patients diagnosed with ALL.

Who should consider this trial

Good fit: Ideal candidates include patients aged 0 to 45 years newly diagnosed with T-lymphoblastic or B-lymphoblastic precursor leukemia.

Not a fit: Patients with specific genetic rearrangements or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

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

How similar studies have performed: Previous studies have shown success with similar collaborative approaches in treating acute lymphoblastic leukemia, indicating a promising potential for this 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 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).

Where this trial is running

Aalborg and 52 other locations

+3 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 → Find more trials like this →
Conditions Leukemia, Acute LymphoblasticLeukemiaAcute LymphoblasticALLALLTogetherLeukaemia
Last reviewed 2026-06-15 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.