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

Official Title

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


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.

Trial Description

Primary Outcome:

  • Overall Survival (OS) Stratum 1 (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)
  • Event free survival (EFS) Stratum 2 (mismatched donor transplantation)
Secondary Outcome:
  • EFS (Stratum 1)
  • Cumulative Incidence of Treatment-related mortality (TRM) for Stratum 1 and 2
  • Cumulative Incidence of Relapse for Stratum 1 and 2
  • acute and late toxicity for Stratum 1 and 2
  • OS (Stratum 2)
Acute and late side effects of TBI in combination with other chemotherapeutic are manifold to the growing organism and include severe organ dysfunction/failure due to toxicity. Although transplant associated mortality was reduced after HSCT in the last decade due to better HLA matching, infection prevention and control, the burden of late complications is still a matter of concern.Growth retardation, hormonal dysfunction, sterility and the risk of secondary cancer are the late consequences of TBI in children.However, so far no prospective study has demonstrated similar outcomes in paediatric ALL using chemo-conditioning regimen before HSCT.The reason for that are manifold: only a minority of children with ALL qualify for allogeneic HSCT as most patients are cured with modern chemotherapy approaches alone. Those with dismal prognosis are treated in HSCT centres that care for patients with different diseases. Therefore it is nearly impossible to answer complex outcome questions in single centres or even in single countries. International cooperation are essential to allow prospective randomized investigation within comparable patient cohorts. This study aims to explore the efficacy and efficiency of two different chemo-conditioning regimens (Flu/Thio with Treo or ivBu) in comparison to the standard conditioning regimen (TBI/VP16). All patients with an indication for HSCT, age > 4 years and a matched donor (MD) or matched sibling donor (MSD) undergo randomisation between these two conditionings. The decision if the irradiation free conditioning is Flu/Thio/Treo or Flu/Thio/ivBu is stratified by country. Patients with age < 4 years receive automatically the irradiation free conditioning. Patients with a mismatched donor are stratified according to the donor's stem cell source (cordblood, haploidentical tx or bone marrow/peripheral blood stem cells).

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