Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation

Completed

Conditions studied: Infection

In brief

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.

Key facts

Study ID

NCT02470208

Run by

Oxford Immunotec

People needed

250

Starts

2015-06-01

Expected to finish

2017-07-01

Last updated by the study team

2017-09-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years.
• Patients who will undergo one of the following types of allogeneic transplantation: matched related donor, matched or mismatched unrelated donor, haploidentical, or cord blood.
• Patients must be seropositive for CMV prior to transplantation, regardless of donor seropositivity.
• 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.
• Patients must be considered suitable for the study by the Investigator.

You may not qualify if…

• 1. Patients with a known active CMV reactivation within 1 month prior to enrollment or during the study's pre-transplant screening period.
• 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.
• Patients who have previously received or are planning to receive a CMV vaccine.
• Patients who are known to be hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) positive.
• Patients who are known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.
• Patients who are participating in or plan to participate in CMV-related drug or vaccine studies.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.