CompletedNot Applicable

Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Allo-HSCT Recipients

Germany175 participantsStarted 2014-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Determination of changes in pp65 and/or IE-1 specific CMI applying T-Track® CMV

Timeframe: days 45, 60 and 80 post Tx as well as at any time between day 45 - 225 in case of CMV-complications

Trial details

NCT IDNCT02156479

SponsorLophius Biosciences GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-04