Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:9/20/2017
Start Date:June 2015
End Date:July 2017

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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.

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.

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.
We found this trial at
11
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Parameswaran Hari, MD, MRCP, MS
Phone: 414-805-3666
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Sherif B. Mossad, MD
Phone: 216-448-0195
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Robin Avery, MD
Phone: 410-502-3561
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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Chicago, Illinois 60637
Principal Investigator: Kathleen Mullane, DO, PharmD
Phone: 773-702-1665
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Chicago, IL
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Detroit, Michigan 48201
Principal Investigator: Pranatharthi H. Chandrasekar, MD
Phone: 313-993-0253
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Detroit, MI
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Duarte, California 91010
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Duarte, CA
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Scott D. Rowley, MD
Phone: 551-996-5013
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Ella J. Ariza-Heredia, MD
Phone: 713-563-2306
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Drew Winston, MD
Phone: 310-794-8600
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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Toronto, Ontario
Principal Investigator: Deepali Kumar, MD MSc FRCPC
Phone: 416-340-4800
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Toronto,
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Worcester, Massachusetts 01605
Principal Investigator: Rajneesh Nath, MD
Phone: 508-856-2024
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Worcester, MA
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