Cytomegalovirus Infection Clinical Trial
— CMV-ACE/ASPECTOfficial title:
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
Verified date | January 2018 |
Source | Cell Medica Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | January 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 16 years or older 2. cytomegalovirus seropositive allogeneic T cell depleted (alemtuzumab-containing conditioning regimen) hematopoietic stem cell transplant recipient with cytomegalovirus (CMV) seropositive unrelated donor 3. Patient Informed consent 1. Prepared to undergo additional study procedures as per study schedule 2. Patient has undergone counselling about risk 4. Donor engraftment (neutrophils > 0.5x109/l)(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion) 5. Single positive cytomegalovirus PCR result (And to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion) 6. The donor will be selected from the Anthony Nolan Trust registry or other donor registries that have approved the protocol and consent procedure. 7. Donor must have met requirements of EU Tissue and Cells Directive(2004/23/EC) as amended and the UK statutory instruments pursuant therein. 8. Healthy, Cytomegalovirus (CMV)seropositive donor - having passed medical for stem cell donation 9. Subject and Donor must have negative serology for Human immunodeficiency virus (HIV), Hepatitis B and C, syphilis 10. human leukocyte antigen (HLA) type A*0101, A*0201, A*2402, B*0702 and B*0801 11. Donor informed consent for stem cell mobilisation leucapheresis and storage Exclusion Criteria: 1. Pregnant or lactating women 2. Co-existing medical problems that would place the patient at significant risk of death due to Graft versus Host Disease (GVHD) or its sequelae 3. Human immunodeficiency virus infection 4. Active acute Graft versus Host Disease (GVHD) > Grade I (to be assessed prior to CMV-specific T cell infusion ) 5. Concurrent use of systemic corticosteroids(to be assessed prior to cytomegalovirus (CMV)-specific T cell infusion ) 6. Organ dysfunction (to be assessed prior to cytomegalovirus-specific T cell infusion ) as measured by: 1. creatinine > 200 uM/l 2. bilirubin > 50 uM/l 3. alanine transferase > 3x upper limit of normal 7. Donor pregnant or lactating 8. Donor platelets < 50x109/l |
Country | Name | City | State |
---|---|---|---|
United Kingdom | QEH Birmingham Hospital | Birmingham | |
United Kingdom | Bristol Royal Hospital | Bristol | |
United Kingdom | Kings College Hospital | London | |
United Kingdom | Royal Free Hospital | London | |
United Kingdom | University College London Hospital | London | |
United Kingdom | Manchester Royal Infirmary | Manchester | |
United Kingdom | The Christie | Manchester | |
United Kingdom | Nottingham University Hospital - City Campus | Nottingham | |
United Kingdom | Churchill Hospital | Oxford |
Lead Sponsor | Collaborator |
---|---|
Cell Medica Ltd | Leukaemia Lymphoma Research, National Health Service, Blood and Transplant, University of Birmingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cytomegalovirus (CMV) specific immune reconstitution | 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) | First two months |
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