Trial Outcomes & Findings for Dried Blood Spot Testing of CMV Detection in HCT Recipients (NCT NCT03910478)
NCT ID: NCT03910478
Last Updated: 2025-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
622 participants
Primary outcome timeframe
At one year after Hematopoietic cell transplantation (HCT)
Results posted on
2025-03-13
Participant Flow
Participants who were considered by their transplant teams to be at risk for late CMV disease and were clinically recommended to continue CMV monitoring after day 100 post-transplant were recruited from 4 clinical sites within the United States. The first participant was enrolled on May 3, 2019 and the last participant was enrolled on July 27, 2023.
Participant milestones
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
59
|
|
Overall Study
COMPLETED
|
68
|
51
|
|
Overall Study
NOT COMPLETED
|
45
|
8
|
Reasons for withdrawal
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
Overall Study
Death
|
13
|
6
|
|
Overall Study
Withdrawal by Subject
|
23
|
2
|
|
Overall Study
Physician Decision
|
5
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Failure to meet continuation criteria
|
2
|
0
|
|
Overall Study
Wouldn't proceed DBS portion, data collection only
|
1
|
0
|
Baseline Characteristics
Dried Blood Spot Testing of CMV Detection in HCT Recipients
Baseline characteristics by cohort
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
n=113 Participants
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
n=59 Participants
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
52.2 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Transplant Site
Fred Hutchinson Cancer Research Center
|
34 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Transplant Site
Memorial Sloan Kettering Cancer Center
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Transplant Site
University of Minnesota Medical School
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Transplant Site
MD Anderson Cancer Center
|
38 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Perceived Ease of Access to Blood Draw Facility
Easy
|
97 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Perceived Ease of Access to Blood Draw Facility
Difficult
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Days from HCT
|
88.6 days
STANDARD_DEVIATION 24.4 • n=5 Participants
|
86.2 days
STANDARD_DEVIATION 15.4 • n=7 Participants
|
87.8 days
STANDARD_DEVIATION 21.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: At one year after Hematopoietic cell transplantation (HCT)Population: The Intention-to-Treat population (ITT) included all participants in the randomized cohort in the intervention group to which they were randomly assigned, regardless of their monitoring compliance and regardless of subsequent withdrawal or deviation from the protocol.
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.
Outcome measures
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
n=113 Participants
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
n=59 Participants
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
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 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: At one year after Hematopoietic cell transplantation (HCT)Population: The mITT population included all participants in the ITT population who had at least one result for the number of clinician-recommended CMV monitoring tests and remained enrolled through their first scheduled clinician recommended CMV monitoring test. Participants were grouped based on the intervention received, where participants that completed at least one self-collected DBS sample were grouped in the DBS arm and all other participants were grouped in the SOC arm.
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.
Outcome measures
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
n=82 Participants
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
n=63 Participants
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
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 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: By 1 year after Hematopoietic cell transplantation (HCT)Population: The Intention-to-Treat population (ITT) included all participants in the randomized cohort in the intervention group to which they were randomly assigned, regardless of their monitoring compliance and regardless of subsequent withdrawal or deviation from the protocol.
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per participant was reported.
Outcome measures
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
n=113 Participants
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
n=59 Participants
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the ITT Population
|
6 number of monitoring tests completed
Interval 0.0 to 45.0
|
11 number of monitoring tests completed
Interval 0.0 to 55.0
|
SECONDARY outcome
Timeframe: By 1 year after Hematopoietic cell transplantation (HCT)Population: The mITT population included all participants in the ITT population who had at least one result for the number of clinician-recommended CMV monitoring tests and remained enrolled through their first scheduled clinician recommended CMV monitoring test. Participants were grouped based on the intervention received, where participants that completed at least one self-collected DBS sample were grouped in the DBS arm and all other participants were grouped in the SOC arm.
The total number of recommended Cytomegalovirus (CMV) monitoring tests that were completed per participant was reported.
Outcome measures
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
n=82 Participants
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
n=63 Participants
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
The Total Number of Recommended Cytomegalovirus (CMV) Monitoring Tests That Were Completed Per Participant in the mITT Population
|
11 number of monitoring tests completed
Interval 0.0 to 45.0
|
11 number of monitoring tests completed
Interval 0.0 to 55.0
|
SECONDARY outcome
Timeframe: By 1 year after Hematopoietic cell transplantation (HCT)Population: The Intention-to-Treat population (ITT) included all participants in the randomized cohort in the intervention group to which they were randomly assigned, regardless of their monitoring compliance and regardless of subsequent withdrawal or deviation from the protocol.
Proven or probable CMV disease is a serious adverse event of special interest. The number of participants experiencing proven or probable CMV disease between Hematopoietic cell transplantation (HCT) and 365 days after HCT.
Outcome measures
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
n=113 Participants
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
n=59 Participants
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable
Possible
|
0 Participants
|
0 Participants
|
|
Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable
Probable
|
0 Participants
|
0 Participants
|
|
Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable
Proven
|
2 Participants
|
2 Participants
|
|
Number of Participants With End-organ Cytomegalovirus (CMV) Disease, Possible and Proven/Probable
Probable/Proven
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: By 1 year after Hematopoietic cell transplantation (HCT)Population: The safety population consist of all enrolled participants that had any safety data collected after randomization.
To evaluate the safety of DBS monitoring, Finger-stick procedure-related Grade 3 AEs were abstracted through medical chart review at quarterly contacts and at the final close-out contact. Participants were considered as meeting the outcome measure if they had at least one finger-stick procedure-related Grade 3 AE during the study period.
Outcome measures
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
n=94 Participants
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
Number of Participants With Finger-stick Procedure-related Grade 3 Adverse Events (AEs) in the DBS Arm
|
0 Participants
|
—
|
Adverse Events
Self-collected Dried Blood Spot (DBS) Monitoring
Serious events: 2 serious events
Other events: 0 other events
Deaths: 16 deaths
Standard Monitoring Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Self-collected Dried Blood Spot (DBS) Monitoring
n=94 participants at risk
Participants collected DBS CMV monitoring with mobile technology support.
DBS Self-Collection Kit: Kit for self-collection of Dried Blood Spot (DBS) samples.
|
Standard Monitoring Control
n=58 participants at risk
Standard care with office based testing.
Standard Control Strategy: Standard of care with office-based testing.
|
|---|---|---|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
0.00%
0/94 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/94 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/94 • Number of events 1 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
0.00%
0/58 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
|
Infections and infestations
Cytomegalovirus duodenitis
|
1.1%
1/94 • Number of events 1 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
0.00%
0/58 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/94 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from time of Hematopoietic cell transplantation (HCT) to 365 days after HCT (final study visit).
All-Cause Mortality was collected for all randomized participants. AEs were assessed differently depending on analysis population and study arm. SAEs of special interest (proven/probable CMV disease) were collected for all participants in the Safety Population. Other AEs considered severe and related to the DBS collection and finger stick procedure were collected for participants in the Safety Population in the DBS arm only; no other AEs were collected in the Standard Monitoring Control Arm.
|
Other adverse events
Adverse event data not reported
Additional Information
Michael Boeckh, MD
Fred Hutchinson Cancer Research Center
Phone: 206-667-6706
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60