CYTHEMAT: 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

• Sponsor: Maimónides Biomedical Research Institute of Córdoba (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03210090
• Collaborator: QIAGEN Gaithersburg, Inc (Industry)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 48
• Patients Per Site: 50
• Patients Per Site Per Month: 1

Study Details

Study Description

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	Intervention/Treatment	Phase
Cytomegalovirus Infection; HSCT

Study Design

• Study Type: Observational
• Anticipated 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: Jan 1, 2016
• Anticipated Primary Completion Date: Dec 31, 2018
• Anticipated Study Completion Date: Dec 31, 2019

Outcome Measures

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 [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-)] [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) [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 [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). [3 years]

   To test the differences in mortality/survival between the three groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Marques de Valdecilla	Santander	Cantabria	Spain
2	Hosìtal Universitario Reina Sofia	Córdoba		Spain	14004

Sponsors and Collaborators

• Maimónides Biomedical Research Institute of Córdoba
• QIAGEN Gaithersburg, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maimónides Biomedical Research Institute of Córdoba
• ClinicalTrials.gov Identifier: NCT03210090
• Other Study ID Numbers: HSCT-CMV-2015-01
• First Posted: Jul 6, 2017
• Last Update Posted: Jul 6, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Cytomegalovirus Infections

Study Results

No Results Posted as of Jul 6, 2017