TriangleNCT04312841 · STUDY IN CONTEXT
Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
Adverse 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.
Clinically significant CMV reactivation be determined per the Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum.
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.
OS 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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- trial label
- Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0005
- source section id
- NCT04312841-om-0005
- source outcome index
- 5
- endpoint
- Genotyping of Mutations in CMV Terminase Complex Genes
- endpoint definition
- 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.
- time origin
- Up to 2 years
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data for this outcome was not collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0000
- source section id
- NCT04312841-om-0000
- source outcome index
- 0
- endpoint
- Cytomegalovirus (CMV) Reactivation
- endpoint definition
- 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.
- time origin
- During prophylaxis treatment (3 months after last dose of alemtuzumab)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data for this outcome was not collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0001
- source section id
- NCT04312841-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Adverse Events Grade 3 or Above
- endpoint definition
- Adverse 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.
- time origin
- Up to 30 days post treatment, an average of 5 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0002
- source section id
- NCT04312841-om-0002
- source outcome index
- 2
- endpoint
- Development of CMV Disease
- endpoint definition
- Clinically significant CMV reactivation be determined per the Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data for this outcome was not collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0003
- source section id
- NCT04312841-om-0003
- source outcome index
- 3
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- 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.
- time origin
- From trial enrollment to the occurrence of progression and death, assessed up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data for this outcome was not collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0004
- source section id
- NCT04312841-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS 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.
- time origin
- From trial enrollment to the occurrence of death due to any cause, assessed up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Letermovir)
- regimen
- 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
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04312841-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Letermovir)
- regimen
- 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
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04312841-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Letermovir)
- regimen
- 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
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04312841-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Letermovir)
- regimen
- 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
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04312841-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Letermovir)
- regimen
- 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
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04312841-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Letermovir)
- regimen
- 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
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04312841-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04312841
- harm key
- EG000
- source section id
- NCT04312841-ae
- event group key
- EG000
- event group label
- Treatment (Letermovir)
- serious affected
- 2
- serious at risk
- 6
- other affected
- 3
- other at risk
- 6
- frequency threshold
- 5
- collection period
- 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
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice