A Prospective Phase II Study to Investigate the Efficacy and Safety of Pre-emptive Cytomegalovirus Adoptive Cellular Therapy in Patients Receiving Allogeneic Haematopoietic Stem Cell Transplant From an Unrelated Donor (CMV-ACE/ASPECT)

NCT01220895 Phase 2 COMPLETED

The purpose of this study is to evaluate the potential clinical benefit of pre-emptive cytomegalovirus (CMV)-specific adoptive cellular therapy following T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) for reducing recurrent CMV reactivation.

Details

Lead sponsor	Cell Medica Ltd
Phase	Phase 2
Status	COMPLETED
Enrolment	52
Start date	2010-10
Completion	2014-01

Conditions

• Cytomegalovirus Infection

Interventions

• CMV-specific T-cells, single infusion following single positive CMV PCR result

Primary outcomes

• Cytomegalovirus (CMV) specific immune reconstitution — First two months
  Primary endpoint will be the peak number of circulating Cytomegalovirus (CMV)-reactive T cells within the first two months, after single positive cytomegalovirus PCR result (or post adoptive cell therapy infusion)

Countries

United Kingdom