NCT00858793|TerminatedPhase 1/2DMC
Study Stopped
A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment
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A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment
Sponsor study identifier
interventional
5
1 country
1
Study Start
November 28, 2008
Actual (reported)Primary Completion
August 31, 2016
Actual (reported)Study Completion
August 31, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 28, 2008
Actual (reported)March 9, 2009
Actual (reported)March 10, 2009
Actual (reported)August 31, 2016
Actual (reported)August 31, 2016
Actual (reported)Adverse events, ECOG performance status and laboratory safety tests
five years after transplantation
Remission status (CR or PR)
five years after transplantation
Any relapse of ARL
five years after transplantation
level and kinetics of engraftment and level of gene marking
five years after transplantation
Viral load
five years after transplantation
CD4 counts
five years after transplantation
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Yla-Herttuala S. Gene therapy moves forward in 2010. Mol Ther. 2011 Feb;19(2):219-20. doi: 10.1038/mt.2010.307. No abstract available.
Nicolaus Kroeger
University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation
5 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2009
First Posted
March 10, 2009
Study Start
November 28, 2008
Actual (reported)Primary Completion
Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
Contact the study team to confirm eligibility.
August 31, 2016
Actual (reported)Study Completion
August 31, 2016
Actual (reported)Last Updated
September 8, 2022
Record last verified: 2022-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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