Letermovir (LMV) Prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients With CMV Seropositive Donors: an Exploratory Study From Spanish GETH/TC Centers

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Status: Not yet enrolling

Conditions: CMV

Study type: Observational

Funder types: Other

Identifiers

NCT06211543

GETH-LMV

Details and patient eligibility

About

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 historical cohort will be included to compare the results of both groups (LMV vs historical cohort).

Full 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. If possible, patients will receive treatment on an outpatient basis except for the hospitalization requirement established in the protocol.

Patients will receive oral or intravenous LMV (if available) at a dose of 480 mg/day. For patients receiving concomitant treatment with cyclosporine, the dose of LMV will be 240 mg/day. According to the standard of care, LMV will be administered daily until week 14 post-transplant for up to 8 weeks (~day 100) starting on day +1.

Patients could be discontinued earlier if, disease progression, patient withdrawal, loss to follow-up, end of study, or death.

After completion of the treatment period, an end-of-treatment visit will occur within 30 days of receipt of the last dose of study drug.

To compare the outcome of the LMV group, a historical cohort will be selected from the national CMV database (GETH-GRUCINI).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

80 participants in 2 patient groups

LMV cohort

Description:

Patients will receive oral or intravenous (if available ) LMV at a dose of 480mg/day. For patients receiving concomitant cyclosporine treatment, the LMV dose will be 240mg/day. LMV will be administered daily through week 14 after transplantation for up to 8 weeks (\~Day 100) beginning

Historical cohort

Description:

An historical control cohort for comparison purposes will be used. Historical data will be obtained from a national CMV data base (GETH-GRUCINI), that includes stem cell transplant recipients from September 2014 to December 2022