Clinical validation of an improved T-Track® CMV assay to assess the functionality of CMV protein-reactive cell-mediated immunity (CMI) and its suitability to determine a protective cut-off value for recurrent CMV reactivations in allo-HSCT recipients
- Conditions
- B25.9Z94.80Cytomegaloviral disease, unspecified
- Registration Number
- DRKS00007113
- Lead Sponsor
- ophius Biosciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 175
I. Patients receiving an allogeneic hematopoietic stem cell transplantation being either CMV seropositive or receiving a graft from a CMV seropositive donor or both, donor and recipient are CMV seropositive (D+/R-, D-/R+, D+/R+)
according to amendment Oct 2015:
Patients receiving an allogeneic hematopoietic stem cell transplantation being CMV seropositive and receiving a graft from a CMV seronegative donor (D-/R+)
II. Patients receiving a first allogeneic hematopoietic stem cell graft
III. Patient at least 18 years of age
IV. Written informed consent
•Seronegativity for CMV both for patient and donor (D-/R-)
according to amendment oct 2015: Seronegativity for CMV both for patient and donor (D-/R-) or seropositivity of donor (D+/R-, D+/R+9)
•Patients receiving standard anti-CMV prophylaxis
•Patients receiving a haploidentical allogeneic hematopoietic stem cell graft
•Patients receiving an umbilical cord blood graft
•Patients treated with Alemtuzumab (e.g. Campath)
•Patient has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator
•Lack or withdrawal of informed consent
•Patient is unable to comply with the visit schedule in the protocol
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation whether screening of CMV-reactive effector cells applying improved T-Track® CMV can predict freedom from relapse of treatment-requiring CMV reactivation following successful antiviral treatment of primary CMV reactivation after allo-HSCT in CMV-seropositive recipients and recipients receiving allografts from CMV-seropositive donors (D+/R+, D+/R-, D-/R+).
- Secondary Outcome Measures
Name Time Method I.Validation whether screening for CMV protein-reactive effector cells applying improved T-Track® CMV can identify patients at reduced risk for primary CMV reactivation requiring antiviral medication.<br>II.Comparison of the suitability of the numbers of pp65 and/or IE-1- specific effector cells applying improved T-Track® CMV and the frequencies of leukocyte subpopulations for the identification of transplant recipients at reduced risk for primary and recurrent CMV reactivation.<br>III.Validation whether the numbers of pp65 and/or IE-1 specific effector cells applying T-Track® CMV correlate with the occurrence and severity of GvHD.<br>IV.Comparison of the suitability of the numbers of pp65 and/or IE-1-specific effector cells applying improved T-Track® CMV and the numbers of CMV-specific CTL applying a multimer staining for CMV epitopes for the identification of transplant recipients at reduced risk for primary and recurrent CMV reactivations.<br>