Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation

Completed

• Conditions: Infection

• Registration Number: NCT02470208
• Lead Sponsor: Oxford Immunotec

Brief 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Status Verified: 2016-06
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the ability of the T SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation.	up to day 182	change in T-SPOT counts from baseline to 182 days post transplant

Secondary Outcome Measures

Name	Time	Method
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
To determine the utility of the T SPOT.CMV assay used before transplantation to determine immune competence against subsequent CMV reactivation.	up to day 182	change in T-SPOT counts from baseline to 182 days post transplant

Trial Locations

Locations (12)

City of Hope; 🇺🇸 Duarte, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Karolinska Univeristy Hostpital; 🇸🇪 Stockholm, Sweden

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Wayne State University - School of Medicine; 🇺🇸 Detroit, Michigan, United States

University Health Network; 🇨🇦 Toronto, Ontario, Canada

The University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States