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

NCT06211543 | Not Yet Recruiting

• 1 other identifier: GETH-LMV
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

CMV

Keywords

CMV; Allogeneic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• CMV DNAemia requiring preemptive treatment or CMV disease

  To determinate the incidence of csCMV infection through week 14 post-SCT.

  Week 14 post-SCT

Secondary Outcomes (14)

• Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +40 post-SCT.

  Day +40 post-SCT

• Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +100 post-SCT.

  Day +100 post-SCT

• Death by any cause and death not related with disease relapse or progression

  Week 14 post-SCT

• Death by any cause non related to relapse

  Week 14 post-SCT

• Death by any cause non related to relapse

  Week 24 post-SCT

Study Arms (2)

LMV cohort

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CMV-seronegative Allogeneic Stem Cell Transplant Recipients with CMV seropositive donors

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Espanol de trasplantes hematopoyeticos y terapia celular: lead

Central Study Contacts

Irene García Cadenas, MD

CONTACT

934893000; IGarciaCa@santpau.cat

Jose Luis Piñana, MD

CONTACT

jlpinana@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 18, 2024
• Study Start: March 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: March 30, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01