Clinical trial NCT03570411: Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
Official title: Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: CMV
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Oxford Immunotec
First posted: 2018-06-27
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 94 HCT recipients and 94 HCT Donors of HCT Recipients on study

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.

Detailed description: T-SPOT response will be measured using the results from the T-SPOT.CMV blood test in both HCT recipients and HCT donors.

A blood sample for the T-SPOT.CMV blood test will be collected from the HCT donor prior to transplant.

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.

HCT recipient participant demographic and clinical characteristics will be collected at enrollment. Additional clinical information will be abstracted from the HCT recipient participants medical record during the study follow-up period. This will include information related to transplant history and outcome, infections, antimicrobial exposure, chemotherapy, and laboratory values related to infectious diseases and immunosuppression.

The feasibility of the T-SPOT.CMV spot count test will be evaluated once the first 30 participants enrolled on study reach day +90. If 75% of patients have at least 1 evaluable samples after engraftment (\> 75,000 per microtiter wells), we will proceed with enrollment. If more \>25% of patients have all their samples deemed not evaluable due to insufficient mononuclear cell count (\<75,000 per microtiter wells) the study will be stopped and concluded as not feasible.

Eligibility criteria: HCT Recipient Inclusion Criteria

* 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.

HCT Recipient Exclusion Criteria

* 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.

HCT Donor Inclusion Criteria

• Approved allogeneic HCT donor for a HCT recipient enrolled on the SPOTCMV protocol

HCT Donor Exclusion Criteria

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Primary outcomes:
measure: Percentage of the first 30 participants with at least one evaluable sample
timeFrame: Day +90 after transplant
measure: Odds ratio of subsequent reactivation
timeFrame: Up to 180 days after enrollment.
Secondary outcomes:
measure: Correlation coefficient of T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count
timeFrame: Up to 180 days after enrollment.
measure: Odds ratio of morbidity
timeFrame: Up to 180 days after enrollment.
measure: Odds ratio of treatment outcomes
timeFrame: Up to 180 days after enrollment.
measure: Hazard ratio of morbidity
timeFrame: Up to 180 days after enrollment.
measure: Hazard ratio of treatment outcomes
timeFrame: Up to 180 days after enrollment.
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Diego Hijano, MD
role: PRINCIPAL_INVESTIGATOR
References: