N/A
N=172
Dried Blood Spot Testing of CMV Detection in HCT Recipients
Cytomegalovirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT03910478 ↗Enrolled (actual)
172
Serious AEs
2.6%
Results posted
Mar 2025
Primary outcome: Primary: 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 — 27; 15 Participants — p=0.8920
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DBS Self-Collection Kit (Device); Standard Control Strategy (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
27; 15 | 0.8920 |
| PRIMARY 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 |
22; 20 | 0.3008 |
| SECONDARY The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the ITT Population |
6; 11 | — |
| SECONDARY The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the mITT Population |
11; 11 | — |
| SECONDARY Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable |
0; 0; 0; 0; 2; 2 | — |
| SECONDARY Number of Participants With Finger-stick Procedure-related Grade 3 Adverse Events (AEs) in the DBS Arm |
— | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
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:
- 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 no
Data sourced from ClinicalTrials.gov (NCT03910478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.