TREATMENT WITH CYTOMEGALOVIRUS (CMV) PP65 SPECIFIC LYMPHOCYTES IN PATIENTS WITH CMV REACTIVATION OR CMV DISEASE AFTER ALLOGENEIC STEM CELL TRANSPLANTATIO

• Conditions: CMV reactivation after allogeneic stem cell transplantation; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024307-27-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 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.
- 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).
Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Life expectation < 3 months.
- End stage irreversible multi-system organ failure.
- Pregnant or lactating women.
- Severe psychological disturbances.
- Patient HIV positive.
- Donor HIV positive.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified