Status:
NOT_YET_RECRUITING
Letermovir (LMV) Prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients With CMV Seropositive Donors: an Exploratory Study From Spanish GETH/TC Centers
Lead Sponsor:
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Conditions:
CMV
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational cohort study. Two cohort will be enrolled: LMV cohort: All patients included in in this study will receive LMV according to standard of care. Historical cohort: an historica...
Detailed Description
All patients will receive treatment wtith LMV according to standard of care. Eligible patients will be enrolled in the study under the supervision of the investigator or designated sub-investigators....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥18 years
- First allogenic HCT
- Pre-HCT patient CMV negative IgG serology with CMV IgG positive donor serostatus
- Able to provide written consent and complete the informed consent
- Absence of CMV DNAemia requiring antiviral therapy within 5 days before initiation of LMV. Low levels CMVDNAemia before the inception of letermovir are allowed
- Exclusion Criteria
- Active pre-emptive therapy for csCMV-I.
- Patients who have received LMV prophylaxis prior to enrollment
- Patients enrolled in a CMV pre-emptive therapy clinical trial
- Glomerular filtration rate (GFR) \</=30 mL/min/1.73m\^2 (equivalent to creatinine clearance \</=10 mL/min)
- Severe hepatic function grade 3-4 CTAE at the time of study entry.
- Suspected or known hypersensitivity to active or inactive ingredients of LMV formulations
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to letermovir.
- Pregnancy or breastfeeding
- Plans to conceive or father children within the projected duration of the trial
- History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study
Exclusion
Key Trial Info
Start Date :
March 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06211543
Start Date
March 30 2024
End Date
March 30 2026
Last Update
January 18 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.