REACT: Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation

• Sponsor: Oxford Immunotec (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02470208
• Collaborator: (none)
• Enrollment: 250
• Locations: 12
• Duration (Months): 25
• Patients Per Site: 20.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection

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

• Study Type: Observational
• Actual Enrollment: 250 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Outcome Measures

Primary Outcome Measures

1. To evaluate the ability of the T SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation. [up to day 182]

   change in T-SPOT counts from baseline to 182 days post transplant

Secondary Outcome Measures

1. 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]

   change in T-SPOT counts from baseline to 182 days post transplant

2. 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

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

2. Patients who have previously received or are planning to receive a CMV vaccine.

3. Patients who are known to be hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) positive.

4. Patients who are known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.

5. Patients who are participating in or plan to participate in CMV-related drug or vaccine studies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	UCLA Medical Center	Los Angeles	California	United States	90095
3	The University of Chicago Medicine	Chicago	Illinois	United States	60637
4	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
5	UMass Memorial Medical Center	Worcester	Massachusetts	United States	01655
6	Wayne State University - School of Medicine	Detroit	Michigan	United States	48201
7	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
8	Cleveland Clinic	Cleveland	Ohio	United States	44195
9	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
10	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
11	University Health Network	Toronto	Ontario	Canada	M5G 2N2
12	Karolinska Univeristy Hostpital	Stockholm		Sweden	14186

Sponsors and Collaborators

• Oxford Immunotec

Investigators

• Principal Investigator: Roy F Chemaly, MD, The University of Texas MD Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oxford Immunotec
• ClinicalTrials.gov Identifier: NCT02470208
• Other Study ID Numbers: US OI 125
• First Posted: Jun 12, 2015
• Last Update Posted: Sep 19, 2017
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Oxford Immunotec: Cytomegalovirus reactivation in stem cell transplant

Study Results

No Results Posted as of Sep 19, 2017