Dried Blood Spot Testing of CMV Detection in HCT Recipients

Completed · Not applicable

Conditions studied: Cytomegalovirus Infection

In brief

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.

Key facts

Study ID: NCT03910478
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 622
Starts: 2019-05-03
Expected to finish: 2024-01-16
Last updated by the study team: 2026-02-25

Who can join

Age: 15 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine — Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
The University of Texas - MD Anderson Cancer Center - Infectious Diseases — Houston, Texas, United States
Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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