Improving treatment for high-risk childhood relapsed 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 study aims to enhance outcomes for children and adolescents with high-risk first relapse of acute lymphoblastic leukemia (ALL) by optimizing treatment strategies and integrating new agents like bortezomib. The study focuses on patients classified as high risk based on specific criteria, who typically have poor responses to standard therapies. By combining bortezomib with conventional treatments, researchers hope to improve survival rates and reduce the need for allogeneic hematopoietic stem cell transplantation. The trial is conducted internationally, involving multiple centers to gather a diverse patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
* Children less than 18 years of age at date of inclusion into the study
* Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse)
* Patient enrolled in a participating centre
* Written informed consent
* Start of treatment falling into the study period
* No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL

Exclusion Criteria:

* Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL
* Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) \> 10 U/l)
* Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of anti-leukemic therapy
* Breast feeding
* Relapse post allogeneic stem-cell transplantation
* Neuropathy \> II°
* The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
* Objection to the study participation by a minor patient, able to object
* Any patient being dependent on the investigator
* No consent is given for saving and propagation of pseudonymized medical data for study reasons
* Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
* Subjects unwilling or unable to comply with the study procedures
* Subjects who are legally detained in an official institute

Where it's running

• Australian & New Zealand Childhood Hematology & Oncology Group
  Clayton, Victoria, Australia Recruiting
• St. Anna Kinderkrebsforschung, CCRI
  Vienna, Austria Recruiting
• Hòpital Universitaire des Enfants Reine Fabiola
  Brussels, Belgium Recruiting
• University Hospital Motol
  Prague, Czechia Recruiting
• Turku University Central Hospital
  Turku, Finland Recruiting
• CHU Nice
  Nice, France Recruiting

Study contacts

• Principal investigator: Arend von Stackelberg, MD — Charite University, Berlin, Germany
• Study coordinator: Arend von Stackelberg, MD
• Email: arend.stackelberg@charite.de
• Phone: +49(0)30-450666

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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.