TREATMENT WITH CYTOMEGALOVIRUS (CMV) PP65-SPECIFIC LYPHOCYTES IN PATIENTS WITH CMV REACTIVATION OR CMV DISEASE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION.

TREATMENT WITH CMV PP65-SPECIFIC T CELLS GENERATED BY USE OF A CMV PP65 PROTEIN-SPANNING PEPTIDE POOL IN PATIENTS WITH CMV REACTIVATION OR CMV DISEASE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24017

Enrollment

Registered

2011-12-13

Start date

2011-11-17

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV reactivation CMV disease CMV reactivatie CMV ziekte virusreactivatie

Interventions

Infusion of CMV pp65-specific T-cells.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 0-75 years; 2. Recipient of alloSCT for standard indication according to national- and European Group for blood and Marrow Transplantation-guidelines (see appendix D); 3. Possibility to obtain PBMC by leukapheresis from the CMV seropositive 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; 4. 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); 5. Written informed consent by the patient and/or parent(s) or legal guardian(s).

Exclusion criteria

Exclusion criteria: 1. Life expectation < 3 months; 2. End stage irreversible multi-system organ failure; 3. Pregnant or lactating women; 4. Severe psychological disturbances; 5. Patient HIV positive; 6. Donor HIV positive.

Design outcomes

Primary

Measure	Time frame
The number of events of acute GvHD, death and all other adverse events.	—

Secondary

Measure	Time frame
1. The number of CMV-specific T cells at different time points after infusion of CMV pp65-specific T cells; 2. The number of complete responses or partial responses of CMV reactivation or CMV disease after infusion of CMV pp65-specific T cells.	—

Contacts

Public ContactP. Balen, van

P.O. Box 9600

stafsecretariaathematologie@lumc.nl+31 (0)71 5262267

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)