Cytovir CMV
CMV~ACE/ASPECT Trial
Cytomegalovirus ~ Alternate Donor Study of Pre-Emptive Cellular Therapy
Overview
The CMV ACE/ASPECT study is a phase II randomised study to investigate the use of adoptive cellular therapy (ACT) in combination with conventional antiviral drug therapy for the treatment of CMV reactivation episodes in patients following allogeneic haematopoietic stem cell transplant from an unrelated donor.
CMV~ACE/ASPECT will recruit 36 patients of which 24 patients will be assigned to receive Cytovir CMV in combination with standard antiviral treatment and 12 patients will receive standard antiviral treatment alone.
The Principal Investigator for this study is Dr Karl Peggs, Senior Lecturer and Consultant in Stem Cell Transplantation and Immunotherapy at UCL Cancer Institute.
The study is due for completion by the end of 2012.
The study is funded, in part, by a grant to the University of Birmingham by Leukaemia Lymphoma Research.
Centres
The study is recruiting at 9 centres across the UK.
- Bristol Children’s Hosp.
- The Christie, Manchester
- The Churchill Hosp., Oxford
- King’s College Hosp., London
- Manchester Royal Infirmary
- Nottingham University Hosp.
- Queen Elizabeth Hosp., Birmingham
- The Royal Free Hosp., London
- University College London Hosp
More detail
The primary endpoint of the study is the attainment of CMV-specific T-cells at the level of 10x106/l within two months after receiving Cytovir CMV. This endpoint is associated with immunity to CMV infection.
Further endpoints examine the incidence and severity of GVHD, use of antiviral drug therapy, incidence of CMV disease and CMV reactivation.