Cytomegalovirus InfectionNCT03910478
Dried Blood Spot Testing of CMV Detection in HCT Recipients
A study testing DBS Self-Collection Kit in people with Cytomegalovirus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
This is a randomized clinical trial to assess whether a subject centered, self-collection of Dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Cytomegalovirus Infection
- What is being tested?
- DBS Self-Collection Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 May 2019to 16 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Randomized Cohort:
- Must be >/= 15 years of age at the time of enrollment
- Must be able to provide written consent and complete the informed consent
- Must have received allogeneic hematopoietic cell transplantation within 60-180 days prior to randomization
- Cytomegalovirus (CMV) seropositive or had a donor who was CMV positive
- One or both of the following:
Show all 33Show fewer
- CMV event* within the first 100 days post-transplant requiring anti-viral treatment
- Receipt of CMV prophylaxis(for at least 30 days) prior to randomization. Continuation of letermovir or acyclovir/valacyclovir (high and low dose) prophylaxis after day 100 per institutional standard of care is permitted * CMV event defined as deoxyribonucleic acid (DNA) detection or disease Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, letermovir, maribavir or acyclovir/valacyclovir (high and low dose)
- Direct availability to the internet either by a computer in the residence or a smart phone
- Had at least one or more of these conditions:
- HLA mismatch*
- umbilical cord blood source**
- Graft versus host disease (GVHD)***
- T-cell depletion**** * Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1
- Use of umbilical cord blood as stem cell source ***Acute or chronic GVHD requiring topical steroid for gastrointestinal (GI) GVHD and/or systemic steroid treatment (>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment
- Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab
- Observation Cohort:
- Must be >/= 15 years of age at the time of enrollment
- Must have one of the following:
- Consented for retrospective studies at their transplant center, or
- Be included under the auspices of the site's IRB approved waiver of additional consent for retrospective studies
- Must have received allogeneic hematopoietic cell transplantation during or within 1 year prior to the conduct of the randomized trial (defined as time during which randomization is done)
- CMV seropositive or had a donor who was CMV positive
- One or both of the following:
- CMV event* within the first 100 days post-transplant requiring anti-viral treatment
- Receipt of CMV prophylaxis(for at least 30 days) prior to registration. Continuation of letermovir prophylaxis or acyclovir/valacyclovir (high and low dose) after day 100 per institutional standard of care is permitted * CMV event defined as DNA detection or disease Anti-viral treatment or prophylaxis includes ganciclovir, valganciclovir, foscarnet, letermovir, maribavir or acyclovir/valacyclovir (high and low dose)
- Meet at least one or more of criteria of the following:
- HLA mismatch*
- umbilical cord blood source**
- GVHD***
- T-cell depletion****
- Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch at one of the following three HLA-gene loci: HLA-A, -B, or -DR, Haploidentical donor, Unrelated donor with at least one mismatch at one of the following four HLA-gene loci: HLA-A, -B, -C and -DRB1
- Use of umbilical cord blood as stem cell source *Acute or chronic GVHD requiring topical steroid for GI GVHD and/or systemic steroid treatment (>/= 1 mg/kg/day of prednisone or equivalent dose of another corticosteroid) within 6 weeks prior to enrollment **Subjects who have received partial or full T-cell depletion (with or without GVHD). T-cell depletion can be given as either ex-vivo or in-vivo for GVHD prophylaxis. T-cell depleting agents include, but are not limited to, anti-thymocyte globulin (ATG) and alemtuzumab
Who cannot join
- Randomized Cohort:
- Inability to fully comprehend the study website and study procedures
- Any other condition, which in the opinion of the investigator would interfere with successful completion of this clinical trial
- Morphological relapse (bone marrow or peripheral blood blast) prior to registration
- Observational Cohort:
- Did not meet all inclusion criteria
- Morphological relapse (bone marrow or peripheral blood blast) prior to registration
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Texas - MD Anderson Cancer Center - Infectious Diseases
Houston, Texas, 77030-4000
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine
Minneapolis, Minnesota, 55455-0356
Memorial Sloan Kettering Cancer Center
New York, New York, 10065-6007
Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases
Seattle, Washington, 98109-4433
About this study
Official title: A Multi-Site, Randomized Trial of Subject-Collected Dried Blood Spot CMV Testing With Mobile Technology Support to Optimize Preemptive Therapy Late After Allogeneic HCT
This is a randomized clinical trial to assess whether a subject centered, self-collection of Dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. In this study, mobile devices will be used to remind HCT survivors to perform CMV monitoring using finger-stick collected DBS testing in their home setting or to visit their doctor's office to perform the test. 150 allogeneic HCT recipients > /= 15 years of age will be randomized (2:1) to DBS monitoring or standard of care (per local institution) monitoring. Duration of study participation is anticipated to be within a range of 26 weeks to 43 weeks. The primary objective is to evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT upon enrollment using subject collected dried blood spot testing.
Read the detailed description
This is a randomized clinical trial to assess whether a subject centered, self-collection of dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. In this study, mobile devices will be used to remind HCT survivors to perform CMV monitoring using finger-stick collected DBS testing in their home setting or to visit their doctor's office to perform the test. 150 allogeneic HCT recipients > /= 15 years of age will be randomized (2:1) to DBS monitoring or standard of care (per local institution) monitoring. Duration of study participation is anticipated to be within a range of 26 weeks to 43 weeks. The primary objective is to evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT upon enrollment using subject collected dried blood spot testing. The secondary objectives are 1) To evaluate the mean difference between the recommended monitoring that each subject completes between the DBS and the control arm. 2) To compare the incidence of CMV disease between the DBS monitoring and standard of care arm; 3) To evaluate the safety of DBS monitoring.
Additionally, an observational cohort of 450 HCT recipients, who consented for retrospective studies and meet eligibility criteria but are not participating in the DBS testing for CMV, will be used to assess whether randomized study sample is representative of the DBS study population and to obtain a population-based estimate of late CMV disease.
- Conditions
- Cytomegalovirus Infection
- Being tested
- DBS Self-Collection Kit, Standard Control Strategy
- Keywords
- Allogeneic, Cytomegalovirus, Dried Blood Spot, Hematopoietic cell transplantation
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS Self-Collection KitDevice
Kit for self-collection of Dried Blood Spot (DBS) samples
Standard Control StrategyOther
Standard of care with office-based testing.
| Study group | Role | What they receive |
|---|---|---|
| Self-collected Dried Blood Spot (DBS) monitoring | Experimental | N=100 Subject collected DBS CMV monitoring with mobile technology support Receives: Device: DBS Self-Collection Kit |
| Standard Monitoring Control | Active comparator | N=50 Standard care with office based testing Receives: Other: Standard Control Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the ITT Population
To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed >90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.
Measured: At one year after Hematopoietic cell transplantation (HCT)
The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the mITT Population
To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed >90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.
Measured: At one year after Hematopoietic cell transplantation (HCT)
Secondary outcomes (4)
The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the ITT Population
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per participant was reported.
Measured: By 1 year after Hematopoietic cell transplantation (HCT)
The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the mITT Population
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per participant was reported.
Measured: By 1 year after Hematopoietic cell transplantation (HCT)
Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable
Proven or probable CMV disease is a serious adverse event of special interest. The number of participants experiencing proven or probable CMV disease between Hematopoietic cell transplantation (HCT) and 365 days after HCT.
Measured: By 1 year after Hematopoietic cell transplantation (HCT)
Number of Participants With Finger-stick Procedure-related Grade 3 Adverse Events (AEs) in the DBS Arm
To evaluate the safety of DBS monitoring, Finger-stick procedure-related Grade 3 AEs were abstracted through medical chart review at quarterly contacts and at the final close-out contact. Participants were considered as meeting the outcome measure if they had at least one finger-stick procedure-related Grade 3 AE during the study period.
Measured: By 1 year after Hematopoietic cell transplantation (HCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start3 May 2019
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910478
- Sponsor's protocol ID
- 16-0098
- Status last verified
- 5 Dec 2024
- First submitted
- 9 Apr 2019
- Last updated
- 25 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site, Randomized Trial of Subject-Collected Dried Blood Spot CMV Testing With Mobile Technology Support to Optimize Preemptive Therapy Late After Allogeneic HCT
- ClinicalTrials.gov ID
- NCT03910478
- Acronym / sponsor ID
- 16-0098
- Conditions
- Cytomegalovirus Infection
- Keywords
- Allogeneic, Cytomegalovirus, Dried Blood Spot, Hematopoietic cell transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 3 May 2019 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Posted 13 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial to assess whether a subject centered, self-collection of Dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. In this study, mobile devices will be used to remind HCT survivors to perform CMV monitoring using finger-stick collected DBS testing in their home setting or to visit their doctor's office to perform the test. 150 allogeneic HCT recipients > /= 15 years of age will be randomized (2:1) to DBS monitoring or standard of care (per local institution) monitoring. Duration of study participation is anticipated to be within a range of 26 weeks to 43 weeks. The primary objective is to evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT upon enrollment using subject collected dried blood spot testing.
Detailed description
This is a randomized clinical trial to assess whether a subject centered, self-collection of dried blood spots (DBS) samples will improve compliance with the clinical recommendation of weekly Cytomegalovirus (CMV) testing of Hematopoietic cell transplantation (HCT) recipients who are at high risk for late CMV disease. In this study, mobile devices will be used to remind HCT survivors to perform CMV monitoring using finger-stick collected DBS testing in their home setting or to visit their doctor's office to perform the test. 150 allogeneic HCT recipients > /= 15 years of age will be randomized (2:1) to DBS monitoring or standard of care (per local institution) monitoring. Duration of study participation is anticipated to be within a range of 26 weeks to 43 weeks. The primary objective is to evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT upon enrollment using subject collected dried blood spot testing. The secondary objectives are 1) To evaluate the mean difference between the recommended monitoring that each subject completes between the DBS and the control arm. 2) To compare the incidence of CMV disease between the DBS monitoring and standard of care arm; 3) To evaluate the safety of DBS monitoring.
Additionally, an observational cohort of 450 HCT recipients, who consented for retrospective studies and meet eligibility criteria but are not participating in the DBS testing for CMV, will be used to assess whether randomized study sample is representative of the DBS study population and to obtain a population-based estimate of late CMV disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-collected Dried Blood Spot (DBS) monitoring | Experimental | Device: DBS Self-Collection KitN=100 Subject collected DBS CMV monitoring with mobile technology support |
| Standard Monitoring Control | Active comparator | Other: Standard Control StrategyN=50 Standard care with office based testing |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (33 listed)
- Must be >/= 15 years of age at the time of enrollment
- Must be able to provide written consent and complete the informed consent
- Must have received allogeneic hematopoietic cell transplantation within 60-180 days prior to randomization
- Cytomegalovirus (CMV) seropositive or had a donor who was CMV positive
- One or both of the following:
Key exclusion criteria (7 listed)
- Inability to fully comprehend the study website and study procedures
- Any other condition, which in the opinion of the investigator would interfere with successful completion of this clinical trial
- Morphological relapse (bone marrow or peripheral blood blast) prior to registration
- Did not meet all inclusion criteria
- Morphological relapse (bone marrow or peripheral blood blast) prior to registration
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 |
|---|---|---|
| DBS Self-Collection KitKit for self-collection of Dried Blood Spot (DBS) samples | Device | Self-collected Dried Blood Spot (DBS) monitoring |
| Standard Control StrategyStandard of care with office-based testing. | Other | Standard Monitoring Control |
Primary outcome
The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the ITT Population
Time frame: At one year after Hematopoietic cell transplantation (HCT)
To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed >90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.
The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the mITT Population
Time frame: At one year after Hematopoietic cell transplantation (HCT)
To evaluate adherence to recommended CMV monitoring duration and interval during the first year after HCT, the number of participants who completed >90% of their recommended CMV monitoring tests at one year after HCT in the DBS and control arms was collected.
4 secondary outcomes
The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the ITT Population
Time frame: By 1 year after Hematopoietic cell transplantation (HCT)
The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the mITT Population
Time frame: By 1 year after Hematopoietic cell transplantation (HCT)
Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable
Time frame: By 1 year after Hematopoietic cell transplantation (HCT)
Number of Participants With Finger-stick Procedure-related Grade 3 Adverse Events (AEs) in the DBS Arm
Time frame: By 1 year after Hematopoietic cell transplantation (HCT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cytomegalovirus Infection
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS Self-Collection Kit in people with Cytomegalovirus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants Who Have Completed >90% of Their Recommended Cytomegalovirus (CMV) Monitoring Tests in the DBS and Control Arms in the ITT Population (time frame: At one year after Hematopoietic cell transplantation (HCT)). 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 25 Feb 2026.