Cytomegalovirus Infections and Infestations Cytomegaloviral disease
Conditions
Interventions
Patients will be randomised to receive pre-emptive infusion of gamma-captured CMV-specific T-cells administered upon first CMV PCR+ result, along with standard monitoring and pre-emptive CMV anti-vira
Sponsors
Cell Medica Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or older, either sex 2. Allogeneic T-cell depleted (alemtuzumab-containing conditioning regimen) haematopoietic stem cell transplant (HSCT) recipient with CMV seropositive unrelated donor 3. Informed consent: 3.1. Prepared to undergo additional study procedures as per study schedule 3.2. Patient has undergone counselling about risk To be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release): 4. Donor engraftment (neutrophils greater than 0.5 x 10^9/l) 5. Single positive CMV polymerase chain reaction (PCR) result
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Co-existing medical problems that would place the patient at significant risk of death due to GvHD or its sequelae 3. Human immunodeficiency virus (HIV) infection To be assessed prior to CMV-specific T cell infusion (for confirmation prior to product release): 4. Active acute GvHD greater than Grade I 5. Concurrent use of systemic corticosteroids 6. Organ dysfunction as measured by: 6.1. Creatinine greater than 200 uM/l 6.2. Bilirubin greater than 50 uM/l 6.3. Alanine aminotransferase (ALT) greater than 3 x upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with a peak number of circulating CMV-reactive T-cells above 10 x 10^6/l within the first two months post single positive PCR result (or ACT infusion), measured in the first two months following ACT infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of GvHD 2. The earliest detection of CMV-reactive T cells in the peripheral blood 3. Duration of CMV antiviral drug therapy (total days), number of in-patient days and number of reactivation episodes All measured on a weekly basis for the first 100 days following infusion and then monthly up to 6 months thereafter. | — |
Countries
United Kingdom
Outcome results
None listed