search
Back to results

Dried Blood Spot Testing of CMV Detection in HCT Recipients

Primary Purpose

Cytomegalovirus Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DBS Self-Collection Kit
Standard Control Strategy
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cytomegalovirus Infection focused on measuring Allogeneic, Cytomegalovirus, Dried Blood Spot, Hematopoietic cell transplantation

Eligibility Criteria

15 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Medical Center, Fairview - Infectious Diseases and International MedicineRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • The University of Texas - MD Anderson Cancer Center - Infectious DiseasesRecruiting
  • Fred Hutchinson Cancer Research Center - Vaccine and Infectious DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-collected Dried Blood Spot (DBS) monitoring

Standard Monitoring Control

Arm Description

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

N=50 Standard care with office based testing

Outcomes

Primary Outcome Measures

The number of participants who have completed >90% of their recommended Cytomegalovirus (CMV) monitoring tests in the DBS and control arms

Secondary Outcome Measures

Number of subjects in DBS and standard of care arms with end-organ Cytomegalovirus (CMV) disease, possible and proven/probable
Number of subjects with finger-stick procedure-related Grade 3 AEs
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per subject

Full Information

First Posted
April 9, 2019
Last Updated
October 19, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT03910478
Brief Title
Dried Blood Spot Testing of CMV Detection in HCT Recipients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2019 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infection
Keywords
Allogeneic, Cytomegalovirus, Dried Blood Spot, Hematopoietic cell transplantation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-collected Dried Blood Spot (DBS) monitoring
Arm Type
Experimental
Arm Description
N=100 Subject collected DBS CMV monitoring with mobile technology support
Arm Title
Standard Monitoring Control
Arm Type
Active Comparator
Arm Description
N=50 Standard care with office based testing
Intervention Type
Device
Intervention Name(s)
DBS Self-Collection Kit
Intervention Description
Kit for self-collection of Dried Blood Spot (DBS) samples
Intervention Type
Other
Intervention Name(s)
Standard Control Strategy
Intervention Description
Standard of care with office-based testing.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
Title
Number of subjects with finger-stick procedure-related Grade 3 AEs
Time Frame
By 1 year after Hematopoietic cell transplantation (HCT)
Title
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per subject
Time Frame
By 1 year after Hematopoietic cell transplantation (HCT)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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 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 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 within 360 days prior to enrollment 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 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 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Boeckh
Phone
12066674898
Email
mboeckh@fhcrc.org
Facility Information:
Facility Name
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0356
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas - MD Anderson Cancer Center - Infectious Diseases
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4000
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center - Vaccine and Infectious Diseases
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-4433
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Dried Blood Spot Testing of CMV Detection in HCT Recipients

We'll reach out to this number within 24 hrs