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Dried Blood Spot Testing of CMV Detection in HCT Recipients

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ClinicalTrials.gov Identifier: NCT03910478
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Device: DBS Self-Collection Kit Other: Standard Control Strategy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Self-collected Dried Blood Spot (DBS) monitoring
N=100 Subject collected DBS CMV monitoring with mobile technology support
 Device: DBS Self-Collection Kit
Kit for self-collection of Dried Blood Spot (DBS) samples
Active Comparator: Standard Monitoring Control
N=50 Standard care with office based testing
 Other: Standard Control Strategy
Standard of care with office-based testing.


Outcome Measures
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Primary Outcome Measures :
  1. The number of participants who have completed >90% of their recommended Cytomegalovirus (CMV) monitoring tests in the DBS and control arms [ Time Frame: At one year after Hematopoietic cell transplantation (HCT) ]

Secondary Outcome Measures :
  1. Number of subjects in DBS and standard of care arms with end-organ Cytomegalovirus (CMV) disease, possible and proven/probable [ Time Frame: By 1 year after Hematopoietic cell transplantation (HCT) ]
  2. Number of subjects with finger-stick procedure-related Grade 3 AEs [ Time Frame: By 1 year after Hematopoietic cell transplantation (HCT) ]
  3. The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per subject [ Time Frame: By 1 year after Hematopoietic cell transplantation (HCT) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Randomized Cohort:

  1. Must be >/= 15 years of age at the time of enrollment
  2. Must be able to provide written consent and complete the informed consent
  3. Must have received allogeneic hematopoietic cell transplantation within 60-180 days prior to randomization
  4. Cytomegalovirus (CMV) seropositive or had a donor who was CMV positive

  5. 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 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, or letermovir
  6. Direct availability to the internet either by a computer in the residence or a smart phone

  7. 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:

  1. Must be >/= 15 years of age at the time of enrollment

  2. 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

  3. Must have received allogeneic hematopoietic cell transplantation within 360 days prior to enrollment
  4. CMV seropositive or had a donor who was CMV positive

  5. 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 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, or letermovir

  6. 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

Exclusion Criteria:

Randomized Cohort:

  1. Inability to fully comprehend the study website and study procedures
  2. Any other condition, which in the opinion of the investigator would interfere with successful completion of this clinical trial
  3. Morphological relapse (bone marrow or peripheral blood blast) prior to registration

Observational Cohort:

  1. Did not meet all inclusion criteria
  2. Morphological relapse (bone marrow or peripheral blood blast) prior to registration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910478


Contacts
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Contact: Michael Boeckh 12066674898 mboeckh@fhcrc.org

Locations
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United States, Minnesota
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine Recruiting
Minneapolis, Minnesota, United States, 55455-0356
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065-6007
United States, Texas
The University of Texas - MD Anderson Cancer Center - Infectious Diseases Recruiting
Houston, Texas, United States, 77030-4000
United States, Washington
Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases Recruiting
Seattle, Washington, United States, 98109-4433
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03910478    
Other Study ID Numbers: 16-0098
HHSN272201600015C
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Allogeneic
Cytomegalovirus
Dried Blood Spot
Hematopoietic cell transplantation
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections