Trial Outcomes & Findings for Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab (NCT NCT04312841)
NCT ID: NCT04312841
Last Updated: 2025-02-28
Results Overview
Defined as the proportion of patients who experience CMV reactivation (CMV deoxyribonucleic acid \[DNA\] by real time polymerase chain reaction \> 500 IU/mL) during prophylaxis period among all patients who receive \>= 90% of planned letermovir doses. The rate will be provided with 95% binomial confidence interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
During prophylaxis treatment (3 months after last dose of alemtuzumab)
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
Treatment (Letermovir)
Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Letermovir: Given PO
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab
Baseline characteristics by cohort
| Measure |
Treatment (Letermovir)
n=6 Participants
Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Letermovir: Given PO
|
|---|---|
|
Age, Continuous
|
74 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
|
Performance Status
Fully Active
|
2 Participants
n=99 Participants
|
|
Performance Status
Restricted
|
2 Participants
n=99 Participants
|
|
Performance Status
Ambulatory
|
1 Participants
n=99 Participants
|
|
Performance Status
Unknown
|
1 Participants
n=99 Participants
|
|
Histology
CTCL-Sezary Syndrome
|
1 Participants
n=99 Participants
|
|
Histology
Erythrodermic Mycosis Fungoides
|
1 Participants
n=99 Participants
|
|
Histology
T-cell Lymphoproliferative Disorder
|
1 Participants
n=99 Participants
|
|
Histology
T-cll Prolymphocytic Leukemia
|
1 Participants
n=99 Participants
|
|
Histology
Unknown
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During prophylaxis treatment (3 months after last dose of alemtuzumab)Population: Data for this outcome was not collected
Defined as the proportion of patients who experience CMV reactivation (CMV deoxyribonucleic acid \[DNA\] by real time polymerase chain reaction \> 500 IU/mL) during prophylaxis period among all patients who receive \>= 90% of planned letermovir doses. The rate will be provided with 95% binomial confidence interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days post treatment, an average of 5 monthsAdverse event data will be described and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 guidelines. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns, especially for grade 3 or above adverse events. To assess tolerability, will also capture the proportion of patients who go off treatment due to adverse events.
Outcome measures
| Measure |
Treatment (Letermovir)
n=6 Participants
Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Letermovir: Given PO
|
|---|---|
|
Number of Participants With Adverse Events Grade 3 or Above
Diarrhea
|
1 participants
|
|
Number of Participants With Adverse Events Grade 3 or Above
White blood cell decreased
|
2 participants
|
|
Number of Participants With Adverse Events Grade 3 or Above
Activated partial thromboplastin time prolonged
|
1 participants
|
|
Number of Participants With Adverse Events Grade 3 or Above
Neutrophil count decreased
|
1 participants
|
|
Number of Participants With Adverse Events Grade 3 or Above
Sinus bradycardia
|
1 participants
|
|
Number of Participants With Adverse Events Grade 3 or Above
Platelet count decreased
|
3 participants
|
|
Number of Participants With Adverse Events Grade 3 or Above
Anemia
|
1 participants
|
|
Number of Participants With Adverse Events Grade 3 or Above
Alkaline phosphatase increased
|
1 participants
|
|
Number of Participants With Adverse Events Grade 3 or Above
Lymphocyte count decreased
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data for this outcome was not collected
Clinically significant CMV reactivation be determined per the Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From trial enrollment to the occurrence of progression and death, assessed up to 2 yearsPopulation: Data for this outcome was not collected
PFS will be estimated with the method of Kaplan-Meier (KM), where KM curves will be drawn to aid with visualization and estimates provided with 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From trial enrollment to the occurrence of death due to any cause, assessed up to 2 yearsOS will be estimated with the method of KM, where KM curves will be drawn to aid with visualization and estimates provided with 95% confidence intervals.
Outcome measures
| Measure |
Treatment (Letermovir)
n=6 Participants
Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Letermovir: Given PO
|
|---|---|
|
Overall Survival (OS)
|
8.3 months
Interval 0.4 to
Due to low accrual the upper limit for the confidence interval was not able to be determined.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: Data for this outcome was not collected
CMV DNA sequence analysis to be performed only in subjects with CMV reactivation. Resistance to letermovir will be monitored by retrospective genotypic analysis of the CMV terminase genes in CMV DNA extracts from selected plasma samples collected at the time of diagnosed CMV reactivation. Samples will be analyzed by standard population sequencing technology through an established contract laboratory with validated protocols in place.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Letermovir)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Letermovir)
n=6 participants at risk
Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Letermovir: Given PO
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Cardiac disorders
Myocardial infarction
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
Other adverse events
| Measure |
Treatment (Letermovir)
n=6 participants at risk
Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Letermovir: Given PO
|
|---|---|
|
Investigations
Platelet Count Decreased
|
50.0%
3/6 • Number of events 3 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Number of events 2 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Adverse Events were collected for patients using NCI CTCAE version 5.0 from the start of study to up to 30 days after finishing the last cycle of treatment; an average of 5 months. All-Cause Mortality was monitored/assessed up to 2 years
|
Additional Information
Dr. John Reneau
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-3196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place