CMV Clinical Trial
Official title:
Letermovir (LMV) Prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients With CMV Seropositive Donors: an Exploratory Study From Spanish GETH/TC Centers
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).
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | March 30, 2026 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Grupo Espanol de trasplantes hematopoyeticos y terapia celular |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +40 post-SCT. | Engraftment incidence and time to engraftment | Day +40 post-SCT | |
Secondary | Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +100 post-SCT. | Engraftment incidence and time to engraftment | Day +100 post-SCT | |
Secondary | Death by any cause and death not related with disease relapse or progression | All-cause mortality week 14 | Week 14 post-SCT | |
Secondary | Death by any cause non related to relapse | Non-relapse Mortality (NRM) | Week 14 post-SCT | |
Secondary | Death by any cause non related to relapse | Non-relapse Mortality (NRM) | Week 24 post-SCT | |
Secondary | Time to onset of all-cause failure of prophylaxis against CMV infection during the 8 weeks of study-drug administration period (day +100 post-transplant) | To evaluate the time to onset of all-cause failure of prophylaxis against CMV infection during the 8 weeks of study-drug administration period (day +100 post-transplant) | Up to 8 weeks of study-drug administration period (day +100 post-transplant) | |
Secondary | Duration of any CMV-antiviral treatment by day 180 post-SCT | To estimate the duration of CMV-antiviral treatments by day 180 post-SCT. | day 180 post-SCT | |
Secondary | Incidence of blips, clinical and analytic characteristics. | To investigate the natural history of blips in the LMV primary prophylaxis (PP) clinical setting | 180 days post-SCT | |
Secondary | Incidence of untreated CMV DNAemia | Incidence of low levels of CMV DNAemia not requiring PET | 180 days post-SCT | |
Secondary | Adverse events according to the CTCAE, physical examination and regular laboratory tests | To evaluate LMV tolerance and safety | 180 days post-SCT | |
Secondary | Incidence of aGVHD within 120 days after HCT and its onset and severity | To evalute de incidence of aGVHD and clinical characteristics. | 120 days post-SCT | |
Secondary | Incidence of relapse within 180 days after HCT and its onset and severity | To evalute de incidence of relapse and clinical characteristics. | 180 days post-SCT | |
Secondary | Incidence of CMV DNAemia requiring PET within 100-180 days after HCT | To establish incidence of late (> d +100) clinically significant CMV DNAemia | From day 100 to day 180 after HCT | |
Secondary | Incidence of non-CMV infections within 180 days after HCT and its onset and severity | To establish de incidence of non-CMV infections. | 180 days post-SCT |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04101136 -
Effect of Atorvastatin on Subclinical Atherosclerosis
|
N/A | |
Recruiting |
NCT06001320 -
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Trans Recip
|
Early Phase 1 | |
Completed |
NCT01923766 -
Cytotoxic T Cells to Prevent Virus Infections
|
Phase 1 | |
Not yet recruiting |
NCT05969743 -
Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease
|
Phase 2 | |
Recruiting |
NCT01011712 -
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
|
||
Recruiting |
NCT06034925 -
Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients
|
Phase 4 | |
Completed |
NCT04840199 -
A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.
|
Phase 2 | |
Terminated |
NCT03502161 -
Clinical Evaluation of the QuantiFERON CMV Assay
|
||
Recruiting |
NCT04056533 -
Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
|
Phase 2 | |
Not yet recruiting |
NCT04280380 -
Cytomegalovirus Infection in Critically Ill Patients and Patients Receiving Anticancer Therapy
|
||
Active, not recruiting |
NCT03924219 -
CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients
|
||
Not yet recruiting |
NCT06453460 -
Prospect Eval of Efficacy of CMV-TCIP Direct Letermovir Prophylax After Allogen Hemato Cell Transpla
|
Phase 2 | |
Completed |
NCT02694484 -
Search Cytomegalovirus in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant
|
N/A | |
Recruiting |
NCT06011486 -
Expansion of Virus-Specific Lymphocytes for Cell Therapy
|
Phase 1 | |
Recruiting |
NCT04017962 -
A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection
|
Phase 2 | |
Terminated |
NCT03570411 -
Evaluating the Clinical Utility of the T-SPOT.CMV Assay for the Prediction of CMV Reactivation Among Pediatric Patients Undergoing Hematopoietic Cell Transplant
|
||
Enrolling by invitation |
NCT04392297 -
Clinical and Immunological Features of the CMV Infection Atypical Course in Immunocompetent Individuals
|
||
Completed |
NCT00872703 -
Does Normal Brain Imaging Predict Normal Neurodevelopmental Outcome in Fetuses With Proven Cytomegalovirus Infection?
|
N/A | |
Active, not recruiting |
NCT01945814 -
Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)
|
Phase 1 | |
Recruiting |
NCT05041426 -
Letermovir for CMV Prevention After Lung Transplantation
|
Phase 2 |