About this trial
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.
Eligibility criteria
Qualifiers
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"
Disqualifiers
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
Trial design
Treatments tested in this trial
- VP16
- TBI
- Thiotepa
- Treosulfan
- Fludarabine
- Busulfan
- ATG Thymoglobulin
- Cyclophosphamide
- Grafalon
Treatment groups
Sponsors and collaborators
St. Anna Kinderkrebsforschung
Lead sponsor
St. Anna Kinderspital, Austria
Sponsor institution
ALL SCTped Forum
Collaborator
European Society for Blood and Marrow Transplantation
Collaborator
ALL-BFM Study Group
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator
Dutch Childhood Oncology Group
Collaborator
Swiss Pediatric Oncology Group
Collaborator
Australian & New Zealand Children's Haematology/Oncology Group
Collaborator