NCT03210090

Brief Summary

Donor and recipient CMV-serostatus is one of the risk factor for CMV infection in solid organ transplantation. Recipients with IgG positive anti-CMV are classified as low-risk patients since it is considered that patients also have specific cellular immunity against CMV. However, investigators group has published that around 25% of solid organ transplant candidates lack CMV-specific CD8+ T-cell response ("humoral/cellular mismatch") and they are at a higher risk of CMV replication after transplantation. The main goal of this study is to analyze the impact of the humoral/cellular mismatch in hematopoietic stem cell transplantation (HSCT) CMV-seropositive donors on the CMV reactivation after HSCT in CMVseropositive recipients. Investigators will study not only the incidence of CMV reactivation but also the severity (duration and peak viral load), CMV disease and survival. CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related donors will be consecutively recruited from Reina Sofía Hospital (Córdoba) and Marqués de Valdecilla Hospital (Santander). Patients will be monitored during 12 months after HSCT. CMV-specific CD8+ T-cell response will be determined in their donors, using QuantiFERON-CMV assay, to know the frequency of humoral/cellular mismatch. Innate and adaptive immune reconstitution will be assessed by flow cytometry and experimental QuantiFERON Monitor assay. CMV-specific CD8+ T-cell reconstitution will be determined using QuantiFERON-CMV assay.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

April 25, 2017

Last Update Submit

July 4, 2017

Conditions

Cytomegalovirus InfectionHSCT

Keywords

Stem cells transplantationCytomegalovirus infectionCMV-Specific Immune responseImmune reconstitutionHumoral/Cellular mismatchInterferon-gamma

Outcome Measures

Primary Outcomes (1)

  • To determine the incidence and severity of CMV reactivation in CMV-seropositive patients whose stem cells come from CMV seropositive donors lacking CMV-specific CD8+ T-Cell response [D+(T-)/R+] in comparison with D+(T+)/R+ and D-/R+ patients

    To determine the incidence and severity of CMV reactivation in CMV-seropositive patients whose stem cells come from CMV seropositive donors lacking CMV-specific CD8+ T-Cell response \[D+(T-)/R+\] in comparison with D+(T+)/R+ and D-/R+ patients

    During the 6 months after transplantation

Secondary Outcomes (4)

  • To analyze the frequency of CMV-seropositive stem cells donors lacking CMV-specific CD8+ T-Cell response [D+(T-)]

    3 years

  • Innate and adaptive immune reconstitution: Units (percentage and absolute number)

    3 years

  • To evaluate the incidence of CMV disease as well as the type and severity of the disease in D+(T-)/R+ vs D-/R+ and D+(T+)/R+ patients

    3 years

  • CMV-specific immune reconstitution: Units (Percentage respect to CD8+ T cells) and interferon-gamma production (IU/mL).

    3 years

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related donors.

You may qualify if:

  • CMV Seropositive patients who receive a HSCT (Bone marrow or peripheral) blood from related donors
  • \>14 years old
  • signed Inform consent form

You may not qualify if:

  • \. HIV, HCV, HBV Infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Marques de Valdecilla

Santander, Cantabria, Spain

RECRUITING

Hosìtal Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Sara Cantisan, PhD

CONTACT

sacanti@hotmail.com

Carmen Clavijo

CONTACT

carmen.clavijo@imibic.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

July 6, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

July 6, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)