NCT02470208

Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Oxford Immunotec · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Infection

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-06-12
• Last updated: 2017-09-19

Locations

12 sites across 3 countries: United States, Canada, Sweden