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

September 18, 2017 updated by: Oxford Immunotec

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: up to day 182
change in T-SPOT counts from baseline to 182 days post transplant
up to day 182

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: up to day 182
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.
Time Frame: up to day 182
up to day 182

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oxford Immunotec

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roy F Chemaly, MD, The University of Texas MD Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • US OI 125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings