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

NCT02156479 | Completed

• 1 other identifier: LB-B1
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cytomegalovirus Infection; GVHD

Keywords

CMV; T-Track CMV; allo-HSCT; CMI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Determination of frequencies of leukocyte subpopulations

  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

Other Outcomes (2)

• 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

• Determination of occurrence and severity of GvHD

  Any time during study period (day 0 - 225)

Study Arms (1)

Allo-HSCT recipients

Patients receiving an allogeneic hematopoietic stem cell transplantation for the first time, being either CMV seropositive or receiving a graft from a CMV seropositive donor or both, donor and recipient are CMV seropositive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving an allogeneic hematopoietic stem cell transplantation for the first time, being either CMV seropositive or receiving a graft from a CMV seropositive donor or both, donor and recipient are CMV seropositive

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lophius Biosciences GmbH: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Related Publications (1)

• Wagner-Drouet E, Teschner D, Wolschke C, Janson D, Schafer-Eckart K, Gartner J, Mielke S, Schreder M, Kobbe G, Kondakci M, Hilgendorf I, von Lilienfeld-Toal M, Klein S, Heidenreich D, Kreil S, Verbeek M, Grass S, Ditschkowski M, Gromke T, Koch M, Lindemann M, Hunig T, Schmidt T, Rascle A, Guldan H, Barabas S, Deml L, Wagner R, Wolff D. Standardized monitoring of cytomegalovirus-specific immunity can improve risk stratification of recurrent cytomegalovirus reactivation after hematopoietic stem cell transplantation. Haematologica. 2021 Feb 1;106(2):363-374. doi: 10.3324/haematol.2019.229252.

  PMID: 31879324 DERIVED

Related Links

• Lophius Biosciences GmbH

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Daniel Wolff, Prof. Dr. med.

  Klinik für Innere Medizin III, Hämatologie und Onkologie Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 5, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

DE (1)