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).
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). ;
| 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
|
||
| 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 | |
| Recruiting |
NCT03858907 -
Cytomegalovirus Risk in Seropositive Kidney Transplant Recipients Stratified by Quantiferon-CMV
|