InfectionREACTNCT02470208
Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation
An observational study of Infection, run by Oxford Immunotec at 12 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Infection
- How many people
- 250 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jun 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
The University of Chicago Medicine
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Wayne State University - School of Medicine
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
UCLA Medical Center
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
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
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.
Read the 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.
- Conditions
- Infection
- Keywords
- Cytomegalovirus reactivation in stem cell transplant
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to day 182
Secondary outcomes (2)
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
Measured: 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.
Measured: up to day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Immunotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roy F Chemaly, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470208
- Sponsor's protocol ID
- US OI 125
- Acronym
- REACT
- Status last verified
- Jun 2016
- First submitted
- 3 Jun 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02470208
- Acronym / sponsor ID
- REACT / US OI 125
- Conditions
- Infection
- Keywords
- Cytomegalovirus reactivation in stem cell transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Oxford ImmunotecIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy F Chemaly, MD principal investigator
M.D. Anderson Cancer Center
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Oxford Immunotec at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.