Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant

NCT03570411 | Terminated

• 2 other identifiers: SPOTCMVNCI-2018-01349
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The ability to distinguish allogeneic hematopoietic cell transplantation (allo-HCT) recipients at risk for cytomegalovirus (CMV) reactivation from those who are not is central for optimal CMV management strategies. Measuring this cell mediated immunity has been proposed as a potent tool to predict those patients at highest risk of CMV reactivation and disease. This study will evaluate the ability of the T-SPOT.CMV test to predict Cytomegalovirus (CMV) reactivation in allogeneic hematopoietic cell transplantation (allo-HCT) pediatric recipients. Primary Objectives: To evaluate feasibility of T-SPOT.CMV spot count test in allo-HCT pediatric recipients. To evaluate association of T-SPOT.CMV spot count in the first sample collected after patient has engrafted with subsequent CMV reactivation in allo-HCT pediatric recipients. Secondary Objectives: To evaluate the correlation between T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count. To explore the relationship between recipient T-SPOT.CMV spot counts and subsequent CMV infection related morbidity and treatment outcomes among pediatric all-HCT recipients.

Conditions

CMV

Outcome Measures

Primary Outcomes (2)

• Percentage of the first 30 participants with at least one evaluable sample

  Percentage of the first 30 participants enrolled on study reach day +90 with at least one evaluable sample will be reported.

  Day +90 after transplant

• Odds ratio of subsequent reactivation

  We define the primary endpoint to the T-SPOT CMV count in the first sample collected after patient has engrafted, which is the time point when one establishes his/her post-transplant immunity. If the count in this sample is less than or equal to 100, the participant will be noted as "low response", while an individual with a spot count greater than 100 will be noted as "high response". Odds ratio of having subsequent CMV reactivation between "low response" and "high response" groups will be estimated.

  Up to 180 days after enrollment.

Secondary Outcomes (5)

• Correlation coefficient of T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count

  Up to 180 days after enrollment.

• Odds ratio of morbidity

  Up to 180 days after enrollment.

• Odds ratio of treatment outcomes

  Up to 180 days after enrollment.

• Hazard ratio of morbidity

  Up to 180 days after enrollment.

• Hazard ratio of treatment outcomes

  Up to 180 days after enrollment.

Study Arms (2)

HCT Recipient

All participants who meet eligibility criteria and consent to enrollment on study. Blood specimens will be collected for the T-SPOT.CMV blood test from HCT recipients over the course of 6 months, starting weekly at Day +1, biweekly starting at Day +45, and monthly starting at day +120. The amount of blood collected at each visit will be based on age.

Diagnostic Test: T-SPOT®.CMV Test

HCT Donor

Approved allogeneic HCT donor for a HCT recipient enrolled on the SPOTCMV protocol A blood sample for the T-SPOT.CMV blood test will be collected from the HCT donor prior to transplant

Diagnostic Test: T-SPOT®.CMV Test

Interventions

T-SPOT®.CMV Test DIAGNOSTIC_TEST

The T-SPOT.CMV test (Oxford Diagnostic Laboratories) measures the strength of T cell responses to CMV specific antigens. Using whole blood samples obtained through a standard blood collection tube, white blood cells (WBC's) are separated and purified. The cells are quantified and placed into specially designed plates where they are challenged with antigens specific to the disease under study. Disease-specific cells responding to these antigens will release immune messenger molecules, called cytokines. We then use chemistry to allow us to visualize those WBCs releasing cytokines (and hence those which react to the antigen), resulting in a spot on the bottom of the plate, corresponding to the footprint of an individual reacting WBC. Finally, we use an automated image analysis system to identify and count each of these spots to give a quantitative readout. That quantitative readout gives us the frequency of responsive disease-specific cells (Oxford Immunotec, 2017).

HCT Donor; HCT Recipient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

94 HCT recipients and 94 HCT Donors of HCT Recipients on study

You may qualify if:

• Less than 18 years old at the time of study enrollment
• Scheduled to receive allogeneic HCT at St Jude Children's Research Hospital
• HCT recipient has a documented seropositive CMV result prior to enrollment OR The HCT recipient is seronegative, but the HCT donor has a seropositive CMV result as documented in the recipient's medical record.

You may not qualify if:

• Any condition or therapy that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the study, or impact the outcome of the study.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Approved allogeneic HCT donor for a HCT recipient enrolled on the SPOTCMV protocol
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Oxford Immunotec: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study Officials

• Diego Hijano, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 27, 2018
• Study Start: July 16, 2018
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

US (1)