Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation (REACT)

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

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.

Study Overview

• Status: Completed
• Conditions: Infection

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 Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network
• Sweden
  • Stockholm, Sweden, 14186
    • Karolinska Univeristy Hostpital
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University - School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in this study will be men or women aged 18 years or older with positive CMV serostatus (R+) who are candidates for allogeneic HSCT.

The patients enrolled are intended to be representative of those who would be anticipated to have T SPOT.CMV testing when it is used in routine clinical practice. Enrollment will be actively managed by the sponsor.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Oxford Immunotec
• Investigators: Principal Investigator: Roy F Chemaly, MD, The University of Texas MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 12, 2015

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Cytomegalovirus reactivation in stem cell transplant
• Other Study ID Numbers: US OI 125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided