Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation
NCT ID: NCT02470208
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2015-06-30
2017-07-31
Brief Summary
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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
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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
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Oxford Immunotec
INDUSTRY
Responsible Party
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Principal Investigators
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Roy F Chemaly, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center
Locations
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City of Hope
Duarte, California, United States
UCLA Medical Center
Los Angeles, California, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Wayne State University - School of Medicine
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University Health Network
Toronto, Ontario, Canada
Karolinska Univeristy Hostpital
Stockholm, , Sweden
Countries
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Other Identifiers
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US OI 125
Identifier Type: -
Identifier Source: org_study_id