drugset / Trial / NCT01423747

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

NCT01423747

Non-randomizedParallel-groupOpen-labelTreatment

Summary

With this protocol the ALL-SZT BFM international study group wants to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family or unrelated matched donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). to evaluate the efficacy of haematopoietic stem cell transplantation (HSCT) from mismatched family or unrelated mismatched donors (MMD) as compared to HSCT from matched sibling donor (MSD) and matched donor (MD). to determine whether therapy has been carried out according to the main haematopoietic stem cell transplantation (HSCT) protocol recommendations. The standardisation of the treatment options during haematopoietic stem cell transplantation (HSCT) from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. to prospectively evaluate and compare the incidence of acute and chronic graft- versus-host-disease (GvHD) after haematopoietic stem cell transplantation (HSCT) from matched sibling donor (MSD), from matched donor (MD) and from mismatched donor (MMD).

Timeline

Start
2003-07
Primary completion
2011-09
Completion
2016-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background ATG Unknown 20 mg/kg
Background ATG Unknown 20 mg/kg
Background Etoposide Small molecule 60 mg/kg
Background Fludarabine Small molecule 30 mg/m2
Background Thiotepa Other / unclassified 5 mg/kg
Background Treosulfan Small molecule 14 g
Background muromonab-CD3 Monoclonal antibody