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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03210090
Other study ID # HSCT-CMV-2015-01
Secondary ID
Status Recruiting
Phase N/A
First received April 25, 2017
Last updated July 4, 2017
Start date January 1, 2016
Est. completion date December 31, 2019

Study information

Verified date July 2017
Source Maimónides Biomedical Research Institute of Córdoba
Contact Sara Cantisan, PhD
Email sacanti@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Spain Hosìtal Universitario Reina Sofia Córdoba
Spain Hospital Marques de Valdecilla Santander Cantabria

Sponsors (2)

Lead Sponsor Collaborator
Maimónides Biomedical Research Institute of Córdoba QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To analyze the frequency of CMV-seropositive stem cells donors lacking CMV-specific CD8+ T-Cell response [D+(T-)] To analyze the frequency of CMV-seropositive stem cells donors lacking CMV-specific CD8+ T-Cell response [D+(T-)] 3 years
Secondary Innate and adaptive immune reconstitution: Units (percentage and absolute number) 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 years
Secondary 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 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
Secondary CMV-specific immune reconstitution: Units (Percentage respect to CD8+ T cells) and interferon-gamma production (IU/mL). To test the differences in mortality/survival between the three groups 3 years
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