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