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Taking peoplePhase 2/3

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Key facts

Where
Brussels, Gent, Leuven, Liège, and Sint-Lambrechts-Woluwe, BelgiumSee the 5 sites
Phase
Phase 2/3

Where in Belgium

  • Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine FabiolaBrussels, BelgiumNo longer taking part
  • Universitair Ziekenhuis GentGent, BelgiumNo longer taking part
  • UZ LeuvenLeuven, BelgiumNo longer taking part
  • Centre Hospitalier Universitaire de LiègeLiège, BelgiumNo longer taking part
  • Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
St. Anna Kinderkrebsforschung
Trial code
NCT01949129EU 2024-512657-24-00
Record updated
4 September 2026
Original description
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.Read full original descriptionShow less

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.

The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

Inclusion: 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: 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); 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; Karnofsky / Lansky score < 50%; subjects unwilling or unable to comply with the study procedures.

ClinicalTrials.gov NCT01949129 · EU CTIS 2024-512657-24-00