CMV reactivation
Conditions
Interventions
Infusion of CMV pp65-specific T cells
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: * age 0-75 year * recipient of alloSCT for standard indication according to national- and European Group for blood and Marrow Transplantation-guidelines (see appendix D) * Possibility to obtain PBMC by leukapheresis from the CMVseropositive donor or availability of peripheral blood stem cell graft (PBSCT) or of a CD34-negative subfraction of a CD34-positively selected PBSCT product of the donor prepared and cryopreserved at a GMP-facility or stem cell center. * CMV reactivation treatment failure (persistent CMV DNA load of more than 1000 cp/ml or CMV disease after 2 weeks of adequate treatment with antiviral therapy or relapse of CMV DNA load of more than 1000 cp/ml within 4 weeks after adequate treatment with antiviral therapy or contraindication for treatment with antiviral therapy at the discretion of the physician) or CMV disease (organ dysfunction (pneumonitis, enteritis, retinitis, encephalitis, hepatitis, and bone marrow suppression) due to CMV infection). * Written informed consent by the patient and/or parent(s) or legal guardian(s).
Exclusion criteria
Exclusion criteria: - Life expectation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - The number of CMV specific T cells at different time points after infusion of CMV pp65-specific T cells. - The number of complete responses or partial responses of CMV reactivation or CMV disease after infusion of CMV pp65-specific T cells. | — |
Primary
| Measure | Time frame |
|---|---|
| - The number of events of acute GvHD, death and all other adverse events. | — |
Countries
Netherlands
Outcome results
None listed