Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-31 @ 8:22 PM
Study NCT ID:
NCT01819558
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2013-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Study of Immune Therapy After Allograft in Patients With Myeloid Hemopathy
Sponsor:
Institut Paoli-Calmettes
Organization:
Study Overview
Official Title:
Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
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:
ALLO-WT1
Brief Summary:
Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.
If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.
6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.
The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.
If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.
6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.
The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: