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

Cytomegalovirus Infection Clinical Trial

— CYTHEMAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03210090
• Other study ID #: HSCT-CMV-2015-01
• 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
• 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

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections
• HSCT

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