Lymphoblastic Leukemia, Acute, Childhood; Clinical Trial
Official title:
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia
With this protocol the ALL-SCT BFM international study group wants
- to evaluate whether hematopoietic stem cell transplantation (HSCT) from matched family
or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).
- to evaluate the efficacy of hematopoietic stem cell transplantation (HSCT)from
mismatched family or unrelated donors (MMD) as compared to HSCT from matched sibling
donors or matched donors.
- to determine whether therapy has been carried out according to the main HSCT protocol
recommendations. The standardisation of the treatment options during 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 HSCT from matched sibling donor (MSD), from
matched donor (MD) and from mismatched donor (MMD).
Patients with high risk or relapsed acute lymphoblastic leukaemia (ALL) have a worse prognosis compared to all other patients with ALL. For these patients additional therapy approaches are required after they have achieved remission with multimodal chemotherapy. Allogeneic haematopoetic stem cell transplantation shows promising results mainly due to an immunological antileukaemic control by the graft-versus-leukaemia effect but treatment related mortality and morbidity remains a serious problem. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01423747 -
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia
|
Phase 3 |