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Impact of the Lack of CMV-Specific CD8+ T Cell Response in CMV-Seropositive Donors in CMV Reactivation After Hematopoietic Stem Cells Transplant in CMV-Seropositive Recipients (CYTHEMAT)

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ClinicalTrials.gov Identifier: NCT03210090
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
QIAGEN Gaithersburg, Inc
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

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.


Condition or disease
Cytomegalovirus Infection HSCT

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Lack of CMV-Specific CD8+ T Cell Response in CMV-Seropositive Donors in CMV Reactivation After Hematopoietic Stem Cells Transplant in CMV-Seropositive Recipients
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 [ Time Frame: During the 6 months after transplantation ]
    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


Secondary Outcome Measures :
  1. To analyze the frequency of CMV-seropositive stem cells donors lacking CMV-specific CD8+ T-Cell response [D+(T-)] [ Time Frame: 3 years ]
    To analyze the frequency of CMV-seropositive stem cells donors lacking CMV-specific CD8+ T-Cell response [D+(T-)]

  2. Innate and adaptive immune reconstitution: Units (percentage and absolute number) [ Time Frame: 3 years ]
    To analyze the differences in the innate, adaptive as well as CMV-specific immune reconstitution between D+(T-)/R+ vs D-/R+ and D+(T+)/R+ patients

  3. 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 [ Time Frame: 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

  4. CMV-specific immune reconstitution: Units (Percentage respect to CD8+ T cells) and interferon-gamma production (IU/mL). [ Time Frame: 3 years ]
    To test the differences in mortality/survival between the three groups


Biospecimen Retention:   Samples With DNA
whole blood


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related donors.
Criteria

Inclusion Criteria:

  1. CMV Seropositive patients who receive a HSCT (Bone marrow or peripheral) blood from related donors
  2. >14 years old
  3. signed Inform consent form

Exclusion Criteria:

1. HIV, HCV, HBV Infection


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210090


Contacts
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Contact: Sara Cantisan, PhD sacanti@hotmail.com
Contact: Carmen Clavijo carmen.clavijo@imibic.org

Locations
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Spain
Hospital Marques de Valdecilla Recruiting
Santander, Cantabria, Spain
Contact: Claudia Gonzalez         
Principal Investigator: Claudia Gonzalez         
Hosìtal Universitario Reina Sofia Recruiting
Córdoba, Spain, 14004
Contact: Sara Cantisan, PhD       sacanti@hotmail.com   
Contact: Carmen Clavijo       carmen.clavijo@imibic.org   
Principal Investigator: Sara Cantisan, PhD         
Sub-Investigator: Carmen Martin         
Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba
QIAGEN Gaithersburg, Inc

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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT03210090     History of Changes
Other Study ID Numbers: HSCT-CMV-2015-01
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maimónides Biomedical Research Institute of Córdoba:
Stem cells transplantation
Cytomegalovirus infection
CMV-Specific Immune response
Immune reconstitution
Humoral/Cellular mismatch
Interferon-gamma

Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases