CMVNCT03570411
Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
An observational study of CMV, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CMV
- What is being tested?
- T-SPOT®.CMV Test
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 22 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 94 HCT recipients and 94 HCT Donors of HCT Recipients on study
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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:
Read more
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.
Read the 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.
- Conditions
- CMV
- Being tested
- T-SPOT®.CMV Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-SPOT®.CMV TestDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Diagnostic Test: T-SPOT®.CMV Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The correlation coefficient between T-SPOT.CMV spot count in donors (one-time measure) and maximal recipient's CMV spot count will be calculated with Pearson's or Spearman's correlation coefficient.
Measured: Up to 180 days after enrollment.
Odds ratio of morbidity
The odds ratio with 95% CI of morbidity will be reported from multiple logistic regression.
Measured: Up to 180 days after enrollment.
Odds ratio of treatment outcomes
The odds ratio with 95% CI of treatment outcomes will be reported from multiple logistic regression.
Measured: Up to 180 days after enrollment.
Hazard ratio of morbidity
The hazard ratio with 95% CI of morbidity will be reported from Cox regression model.
Measured: Up to 180 days after enrollment.
Hazard ratio of treatment outcomes
The hazard ratio with 95% CI of treatment outcomes will be reported from Cox regression model.
Measured: Up to 180 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start16 Jul 2018
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Why it stopped: The company that was contracted to conduct study specific testing was sold and new management chose to pursue interests other than CMV.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMVStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Immunotec
- Responsible party
- Sponsor
- Investigators
- Diego Hijano, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570411
- Sponsor's protocol ID
- SPOTCMV
- Other IDs
- NCI-2018-01349
- Status last verified
- Jun 2019
- First submitted
- 31 May 2018
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03570411
- Acronym / sponsor ID
- SPOTCMV
- Conditions
- CMV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The company that was contracted to conduct study specific testing was sold and new management chose to pursue interests other than CMV.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Oxford Immunotec
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCT Recipient | – | Diagnostic Test: T-SPOT®.CMV TestAll 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. |
| HCT Donor | – | Diagnostic Test: T-SPOT®.CMV TestApproved 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 94 HCT recipients and 94 HCT Donors of HCT Recipients on study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-SPOT®.CMV TestThe 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). | Diagnostic test | HCT Donor, HCT Recipient |
Primary outcome
Percentage of the first 30 participants with at least one evaluable sample
Time frame: Day +90 after transplant
Percentage of the first 30 participants enrolled on study reach day +90 with at least one evaluable sample will be reported.
Odds ratio of subsequent reactivation
Time frame: Up to 180 days after enrollment.
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.
5 secondary outcomes
Correlation coefficient of T-SPOT.CMV spot count in donors with subsequent recipient CMV spot count
Time frame: Up to 180 days after enrollment.
Odds ratio of morbidity
Time frame: Up to 180 days after enrollment.
Odds ratio of treatment outcomes
Time frame: Up to 180 days after enrollment.
Hazard ratio of morbidity
Time frame: Up to 180 days after enrollment.
Hazard ratio of treatment outcomes
Time frame: Up to 180 days after enrollment.
Results and safety
The study was stopped early (reason given: The company that was contracted to conduct study specific testing was sold and new management chose to pursue interests other than CMV.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for CMV
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EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Hijano, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The company that was contracted to conduct study specific testing was sold and new management chose to pursue interests other than CMV.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the first 30 participants with at least one evaluable sample (time frame: Day +90 after transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.