Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
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Last updated:9th Sep 2013
The ALL SCTped 2012 FORUM is a multinational, multi-centre, randomized, controlled, prospective seamless phase II/III study for the therapy and therapy optimisation for children and adolescents with ALL in CR, who have an indication for HSCT (hematopoetic stem cell transplantation) with a myeloablative conditioning regimen. The stratification and randomisation of patients in first and following remission according to the individual transplantation modalities rests upon an indication for allogeneic HSCT AND on the availability of a suitable donor within the individual transplantation groups. Main objectives - Objective 1: Randomisation of TBI vs non-TBI conditioning regimen for patients with a HLA matched-sibling donor or unrelated HLA matched donor. We aim at showing that a non-total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). - Objective 2: Stratification of patients with a HLA mismatched donor according to stem cell source. We aim at exploring event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members with non TBI-conditioning regimen.
|Study start date||2013-09-09|