Stem cell transplantation for children and adolescents with acute lymphoblastic leukaemia

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 trial investigates the effectiveness of allogeneic stem cell transplantation (HSCT) in children and adolescents diagnosed with acute lymphoblastic leukaemia (ALL) who are in complete remission. The study aims to determine if a chemotherapy-based conditioning regimen can replace total body irradiation (TBI) before HSCT, potentially reducing late complications associated with TBI. It is a multinational, multicenter, controlled, prospective study that involves stratifying patients based on their individual transplantation modalities and donor availability. The trial seeks to gather data from a diverse patient population to improve treatment outcomes for those with high-risk ALL.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

* age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years
* indication for allogeneic HSCT
* complete remission (CR) before HSCT
* written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form"
* no pregnancy
* no secondary malignancy
* no previous HSCT
* HSCT is performed in a study participating centre

Exclusion Criteria:

* patients who do not fulfil the inclusion criteria
* Non Hodgkin-Lymphoma
* the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
* no consent is given for saving and propagation of anonymous 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)
* Karnofsky / Lansky score \< 50%
* subjects unwilling or unable to comply with the study procedures

Where it's running

• Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA
  Buenos Aires, Argentina Recruiting
• Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit
  La Plata, Argentina Recruiting
• Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie
  Graz, Austria Recruiting
• Universitätsklinik für Kinder- und Jugendheilkunde
  Innsbruck, Austria Recruiting
• St. Anna Children's Hospital, Vienna, Austria
  Vienna, Austria Recruiting
• Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
  Brussels, Belgium Recruiting

+69 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Christina Peters, Prof. MD PhD
• Email: christina.peters@stanna.at
• Phone: +43140170

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.