Clinical Trial: High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
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 Summary:
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Current Primary Outcome: Adverse events, ECOG performance status and laboratory safety tests [ Time Frame: five years after transplantation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Remission status (CR or PR) [ Time Frame: five years after transplantation ]
- Any relapse of ARL [ Time Frame: five years after transplantation ]
- level and kinetics of engraftment and level of gene marking [ Time Frame: five years after transplantation ]
- Viral load [ Time Frame: five years after transplantation ]
- CD4 counts [ Time Frame: five years after transplantation ]
Original Secondary Outcome: Same as current
Information By: Universitätsklinikum Hamburg-Eppendorf
Dates:
Date Received: March 9, 2009
Date Started: October 2008
Date Completion: October 2017
Last Updated: May 12, 2015
Last Verified: May 2015