Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation

NCT02470208 | Completed

• 1 other identifier: US OI 125
• Study Type: observational
• Target: 250
• Locations: 3 countries
• Sites: 12

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.

Conditions

Infection

Keywords

Cytomegalovirus reactivation in stem cell transplant

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

  up to day 182

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. Patients with a known active CMV reactivation within 1 month prior to enrollment or during the study's pre-transplant screening period.
• \. 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.
• \. Patients who have previously received or are planning to receive a CMV vaccine.
• \. Patients who are known to be hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) positive.
• \. Patients who are known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.
• \. Patients who are participating in or plan to participate in CMV-related drug or vaccine studies.

Sponsors & Collaborators

• Oxford Immunotec: lead

Study Sites (12)

City of Hope

Duarte, California, 91010, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Wayne State University - School of Medicine

Detroit, Michigan, 48201, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Karolinska Univeristy Hostpital

Stockholm, 14186, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Infections

Study Officials

• Roy F Chemaly, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 12, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2016-06

Locations

SE (1); US (10); CA (1)