Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00858793
Status:
TERMINATED
Last Update Posted:
2022-09-08
First Post:
2009-03-09
Brief Title:
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A leukaemia case was reported in patient treated with a similar vector For safety risk we stopped recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patient stem cells will be mobilized with induction chemotherapy R-ICE and G-CSF If sufficient cells can be mobilized patients will be treated with high-dose chemotherapy and a transplant of autologous CD34 cells transduced with an antiviral vector M87o If autologous CD34 yield is insufficient allogeneic gene-modified cells will be given if a compatible donor is available To minimize risk of transplant failure a second unmodified CD34 cell transplant will be given one week after the first transplant
Detailed Description:
None
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