Dried Blood Spot Testing of CMV Detection in HCT Recipients

NCT03910478 | Completed Results FDA Device

• 1 other identifier: 16-0098
• Study Type: interventional
• Target: 622
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cytomegalovirus Infection

Keywords

Allogeneic; Cytomegalovirus; Dried Blood Spot; Hematopoietic cell transplantation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  By 1 year after Hematopoietic cell transplantation (HCT)

• Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable

  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

  By 1 year after Hematopoietic cell transplantation (HCT)

Study Arms (2)

Self-collected Dried Blood Spot (DBS) monitoring

EXPERIMENTAL

N=100 Subject collected DBS CMV monitoring with mobile technology support

Device: DBS Self-Collection Kit

Standard Monitoring Control

ACTIVE COMPARATOR

N=50 Standard care with office based testing

Other: Standard Control Strategy

Interventions

DBS Self-Collection Kit DEVICE

Kit for self-collection of Dried Blood Spot (DBS) samples

Self-collected Dried Blood Spot (DBS) monitoring

Standard Control Strategy OTHER

Standard of care with office-based testing.

Standard Monitoring Control

Eligibility Criteria

• Age: 15 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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:
• Morphological relapse (bone marrow or peripheral blood blast) prior to registration

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine

Minneapolis, Minnesota, 55455-0356, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065-6007, United States

Location

The University of Texas - MD Anderson Cancer Center - Infectious Diseases

Houston, Texas, 77030-4000, United States

Location

Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases

Seattle, Washington, 98109-4433, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Michael Boeckh, MD
• Organization: Fred Hutchinson Cancer Research Center

mboeckh@fredhutch.org

206-667-6706

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: May 3, 2019
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: February 25, 2026
• Results First Posted: March 13, 2025

Record last verified: 2024-12-05

Locations

US (4)