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 TRANSPLANTATIO

Phase 2

Completed

• Conditions: CMV reactivation; 10047438

• Registration Number: NL-OMON36436
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-01-01
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

- 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The number of events of acute GvHD, death and all other adverse events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The number of CMV specific T cells at different time points after infusion of<br /><br>CMV pp65-specific T cells.<br /><br>- The number of complete responses or partial responses of CMV reactivation or<br /><br>CMV disease after infusion of CMV pp65-specific T cells.</p><br>