Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation

Infection Clinical Trial

— REACT  

Official title:

A Prospective Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation Events - Assessed by a CMV-Specific T-SPOT Assay: The REACT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470208
• Other study ID #: US OI 125
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: September 18, 2017
• Start date: June 2015
• Est. completion date: July 2017

Study information

• Verified date: June 2016
• Source: Oxford Immunotec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the ability of the T-SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation.

To determine the utility of the T-SPOT.CMV assay used before transplantation to determine immune competence against subsequent CMV reactivation and to determine the utility of the T-SPOT.CMV assay used after transplantation to determine immune competence against subsequent CMV reactivation.

Description:

In this prospective, non-randomized, observer-blind observational study, up to 200 patients who meet the study's eligibility criteria will be enrolled at up to 20 study centers. Enrollment will be actively managed by the sponsor.

Blood samples will be collected up to 14 days before transplantation, and then at 2-week intervals for the 6 months after the transplant procedure.

Study duration: 15 months: 9 months to enroll all patients, with 6 months (182 days) of participation for each patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age =18 years.

2. Patients who will undergo one of the following types of allogeneic transplantation:

matched related donor, matched or mismatched unrelated donor, haploidentical, or cord blood.

3. Patients must be seropositive for CMV prior to transplantation, regardless of donor seropositivity.

4. Institutional Review Board (IRB)-approved written Informed Consent and privacy agreement per national regulation (e.g., Health Insurance Portability and Accountability Act [HIPAA] for sites in the USA) must be obtained from the patient or the patient's legally authorized representative prior to any study-specific procedures.

5. Patients must be considered suitable for the study by the Investigator.

Exclusion Criteria:

• 1. Patients with a known active CMV reactivation within 1 month prior to enrollment or during the study's pre-transplant screening period.

2. Patients who have received any antiviral therapy active against CMV other than acyclovir and valacyclovir (i.e., foscarnet, ganciclovir, valganciclovir, or cidofovir) during the month prior to enrollment.

3. Patients who have previously received or are planning to receive a CMV vaccine.

4. Patients who are known to be hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) positive.

5. Patients who are known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.

6. Patients who are participating in or plan to participate in CMV-related drug or vaccine studies.

Related Conditions & MeSH terms

• Infection

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
Sweden	Karolinska Univeristy Hostpital	Stockholm
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	The University of Chicago Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Wayne State University - School of Medicine	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	UCLA Medical Center	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Immunotec

Countries where clinical trial is conducted

United States,  Canada,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the ability of the T SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation.	change in T-SPOT counts from baseline to 182 days post transplant	up to day 182
Secondary	To determine the utility of the T SPOT.CMV assay used before transplantation to determine immune competence against subsequent CMV reactivation.	change in T-SPOT counts from baseline to 182 days post transplant	up to day 182
Secondary	To determine the utility of the T SPOT.CMV assay used after transplantation to determine immune competence against subsequent CMV reactivation.		up to day 182