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Trial record 5 of 6 for:    oxford immunotec

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

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ClinicalTrials.gov Identifier: NCT02470208
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
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
Actual Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
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
Study Start Date : June 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes




Primary Outcome Measures :
  1. To evaluate the ability of the T SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation. [ Time Frame: up to day 182 ]
    change in T-SPOT counts from baseline to 182 days post transplant


Secondary Outcome Measures :
  1. To determine the utility of the T SPOT.CMV assay used before transplantation to determine immune competence against subsequent CMV reactivation. [ Time Frame: up to day 182 ]
    change in T-SPOT counts from baseline to 182 days post transplant

  2. To determine the utility of the T SPOT.CMV assay used after transplantation to determine immune competence against subsequent CMV reactivation. [ Time Frame: up to day 182 ]

Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470208


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

Responsible Party: Oxford Immunotec
ClinicalTrials.gov Identifier: NCT02470208     History of Changes
Other Study ID Numbers: US OI 125
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Oxford Immunotec:
Cytomegalovirus reactivation in stem cell transplant