Trial Outcomes & Findings for A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection (NCT NCT04017962)
NCT ID: NCT04017962
Last Updated: 2025-08-11
Results Overview
Clinically significant CMV viremia defined as: Any level CMV DNAemia requiring preemptive treatment per Institutional standard of care at each participating Institution.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
14 weeks
Results posted on
2025-08-11
Participant Flow
Participant milestones
| Measure |
Hematopoietic Cell Transplantation/HCT
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
66
|
|
Overall Study
COMPLETED
|
26
|
66
|
|
Overall Study
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
| Measure |
Hematopoietic Cell Transplantation/HCT
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Discontinued LTV
|
5
|
0
|
Baseline Characteristics
A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection
Baseline characteristics by cohort
| Measure |
Hematopoietic Cell Transplantation/HCT
n=36 Participants
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
n=66 Participants
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
63 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 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
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: Outcome measure relevant for Hematopoietic Cell Transplantation/HCT cohort only.
Clinically significant CMV viremia defined as: Any level CMV DNAemia requiring preemptive treatment per Institutional standard of care at each participating Institution.
Outcome measures
| Measure |
Hematopoietic Cell Transplantation/HCT
n=36 Participants
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
|---|---|---|
|
Clinically Significant CMV Viremia for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Participants with clinically significant CMV viremia
|
5 Participants
|
0 Participants
|
|
Clinically Significant CMV Viremia for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Participants without clinically significant CMV viremia
|
31 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Outcome measure relevant for Hematopoietic Cell Transplantation/HCT cohort only.
Emergence of Letermovir-resistant CMV Virus in Patients with breakthrough clinically significant CMV viremia.
Outcome measures
| Measure |
Hematopoietic Cell Transplantation/HCT
n=36 Participants
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
|---|---|---|
|
Number of Participants With Breakthrough Clinically Significant CMV Viremia With Emergence of Letermovir-resistant CMV Virus for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts with breakthrough clinically significant CMV viremia and Letermovir-resistant CMV Virus
|
2 Participants
|
0 Participants
|
|
Number of Participants With Breakthrough Clinically Significant CMV Viremia With Emergence of Letermovir-resistant CMV Virus for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts w/breakthrough clinically significant CMV viremia w/out Letermovir-resistant CMV Virus
|
2 Participants
|
0 Participants
|
|
Number of Participants With Breakthrough Clinically Significant CMV Viremia With Emergence of Letermovir-resistant CMV Virus for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts without breakthrough clinically significant CMV viremia
|
32 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Outcome measure relevant for Hematopoietic Cell Transplantation/HCT cohort only.
Outcome measures
| Measure |
Hematopoietic Cell Transplantation/HCT
n=36 Participants
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
|---|---|---|
|
CMV End Organ Disease for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts with CMV end organ disease
|
0 Participants
|
0 Participants
|
|
CMV End Organ Disease for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts without CMV end organ disease
|
36 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Outcome measure relevant for Hematopoietic Cell Transplantation/HCT cohort only.
Outcome measures
| Measure |
Hematopoietic Cell Transplantation/HCT
n=36 Participants
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
|---|---|---|
|
CMV Related Death for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts with CMV related death
|
0 Participants
|
0 Participants
|
|
CMV Related Death for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts without CMV related death
|
36 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Outcome measure relevant for Hematopoietic Cell Transplantation/HCT cohort only.
Outcome measures
| Measure |
Hematopoietic Cell Transplantation/HCT
n=36 Participants
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
|---|---|---|
|
Adverse Events at Least Possibly Related to Letermovir by the Treating Physician for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts with AE's at least possibly related to Letermovir
|
0 Participants
|
0 Participants
|
|
Adverse Events at Least Possibly Related to Letermovir by the Treating Physician for Hematopoietic Cell Transplantation/HCT Participants in the Interventional Cohort Only
Pts without AE's at least possibly related to Letermovir
|
36 Participants
|
0 Participants
|
Adverse Events
Hematopoietic Cell Transplantation/HCT
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Observational Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hematopoietic Cell Transplantation/HCT
n=36 participants at risk
INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection.
|
Observational Cohort
n=66 participants at risk
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
|
|---|---|---|
|
General disorders
Death NOS
|
5.6%
2/36 • 14 weeks
|
0.00%
0/66 • 14 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Genovefa Papanicolaou, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-6483
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place