Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01423500
Status:
UNKNOWN
Last Update Posted:
2015-06-26
First Post:
2011-08-23
Brief Title:
ALL-SCT BFM International- HSCT in Children and Adolescents With ALL
Sponsor:
St Anna Kinderkrebsforschung
Organization:
St Anna Kinderkrebsforschung
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALL-SCT-BFMi
Brief Summary:
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 HSCTfrom 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
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 HSCTfrom 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None