Cytomegalovirus Infection Clinical Trial
— AlloProtectCMVOfficial title:
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
NCT number | NCT02156479 |
Other study ID # | LB-B1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | April 2018 |
Verified date | August 2018 |
Source | Lophius Biosciences GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study in a cohort of allo-HSCT recipients aims to validate the suitability of an
improved T-Track® CMV assay to assess the functionality of CMV protein-reactive effector
cells and its suitability to determine cut-off values mediating protection from recurrent CMV
reactivations in allo-HSCT recipients.
Lophius T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess
the functionality of a network of clinically relevant CMV-reactive effector cells. It is
based on the stimulation of peripheral blood mononuclear cells (PBMC) with activated
immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific
CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.
Status | Completed |
Enrollment | 175 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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+) - Patients receiving a first allogeneic hematopoietic stem cell graft - Patient at least 18 years of age - Written informed consent Exclusion Criteria: - Seronegativity for CMV both for patient and donor (D-/R-) - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Regensburg | Regensburg |
Lead Sponsor | Collaborator |
---|---|
Lophius Biosciences GmbH | German Federal Ministry of Education and Research |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Determination of numbers of CMV-specific CTL applying a multimer staining for CMV epitopes | In parallel withT-Track® CMV, thus days 45, 60 and 80 post Tx as well as at any time between day 45 - 225 in case of CMV-complications, optional | ||
Other | Determination of occurrence and severity of GvHD | Any time during study period (day 0 - 225) | ||
Primary | Determination of changes in pp65 and/or IE-1 specific CMI applying T-Track® CMV | days 45, 60 and 80 post Tx as well as at any time between day 45 - 225 in case of CMV-complications | ||
Secondary | Changes in CMV viral load measured by CMV-PCR | As defined in the respective guidelines of the participating institutes, at least in parallel with T-Track® CMV, any time between day 0 - 225 | ||
Secondary | Determination of frequencies of leukocyte subpopulations | Numbers of naïve (CD45RA) and memory (CD45RO) CD4 and CD8 positive T cells (CD3) as well as NK cells (CD56) and monocytes (CD14) determined by flow cytometry | In parallel with T-Track® CMV, thus days 45, 60 and 80 post Tx as well as at any time between day 45 - 225 in case of CMV-complications |
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