New treatment options for children and adolescents with acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sydney Children's Hospital
  Sydney, Australia Recruiting
• The Children's Hospital at Westmead
  Westmead, Australia Recruiting
• Univ.Klinik für Kinder- und Jugendheilkunde Graz
  Graz, Austria Recruiting
• Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck
  Innsbruck, Austria Recruiting
• Kepler Universitätsklinikum
  Linz, Austria Recruiting
• LKH Salzburg
  Salzburg, Austria Recruiting

+65 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Martin Schrappe, MD — Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel
• Study coordinator: Anja Möricke, MD
• Email: a.moericke@pediatrics.uni-kiel.de
• Phone: +4943150020150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.