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New treatment options for children and adolescents with acute lymphoblastic leukemia

International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

Phase 3 Interventional University Hospital Schleswig-Holstein · NCT03643276

This study is testing new treatment options for children and teens with acute lymphoblastic leukemia to see if combining standard chemotherapy with other therapies can help them live longer without their cancer coming back.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment5000 (estimated)
AgesN/A to 17 Years
SexAll
SponsorUniversity Hospital Schleswig-Holstein Academic / other
Drugs / interventionschemotherapy, blinatumomab, immunotherapy, Methotrexate, Cyclophosphamide
Locations115 sites (Sydney and 114 other locations)
Trial IDNCT03643276 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates new treatment protocols for children and adolescents diagnosed with acute lymphoblastic leukemia (ALL). It employs a risk-stratified approach to tailor therapies based on genetic factors and treatment responses, utilizing advanced methods like minimal residual disease testing. The trial includes randomized comparisons of standard chemotherapy with additional therapies such as the proteasome inhibitor bortezomib and the immunotherapy blinatumomab. The goal is to improve event-free survival rates in patients categorized into different risk groups.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents under 18 years old with newly diagnosed acute lymphoblastic leukemia or mixed phenotype acute leukemia.

Not a fit: Patients with Philadelphia chromosome-positive ALL or those who have received prior cytostatic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to more effective and less toxic treatment options for pediatric patients with ALL.

How similar studies have performed: Other studies have shown promising results with similar risk-stratified approaches and the use of immunotherapy in treating pediatric ALL.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* newly diagnosed acute lymphoblastic leukemia or
* newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
* biphenotypic with a dominant T or B lineage assignment
* bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
* newly diagnosed acute undifferentiated leukemia
* age \< 18 years (up to 17 years and 365 days) at the day of diagnosis
* patient enrolled in a participating center
* written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.

Exclusion Criteria:

* Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
* bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset
* pre-treatment with cytostatic drugs
* glucocorticoid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
* treatment started according to another protocol
* underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…)
* ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
* evidence of pregnancy or lactation period
* Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of anti-leukemic therapy
* participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor
* live vaccine immunization within 2 weeks before start of protocol treatment

Where this trial is running

Sydney and 114 other locations

+65 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 Acute Lymphoblastic Leukemia, PediatricAcute Lymphoblastic LeukemiaChildhoodPediatricImmunotherapyBlinatumomabProteasome InhibitorBispecific antibody
Last reviewed 2026-06-10 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.