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Sponsor: St. Anna Kinderkrebsforschung
Conditions: Acute Lymphoblastic Leukaemia
Interventions: VP16, TBI, Thiotepa, Treosulfan, Fludarabine
Countries: Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Croatia
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.
Sex: ALL
Age: 1 Month to 18 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Buenos Aires, Argentina
- La Plata, Argentina
- Melbourne, Australia
- Perth, Australia
- Randwick, Australia
- South Brisbane, Australia
- Sydney, Australia
- Graz, Austria
- Innsbruck, Austria
- Vienna, Austria
- Minsk, Belarus
- Brussels, Belgium
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Calgary, Canada
- Montral, Canada
- Montreal, Canada
- Toronto, Canada
- Vancouver, Canada
- Winnipeg, Canada
- Santiago, Chile
- Zagreb, Croatia
- Prague, Czechia
- Copenhagen, Denmark
- Helsinki, Finland
- Bordeaux, France
- Clermont-Ferrand, France
- Grenoble, France
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