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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| CMV DNAemia requiring preemptive treatment or CMV disease | To determinate the incidence of csCMV infection through week 14 post-SCT. | Week 14 post-SCT |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +100 post-SCT. |
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Inclusion Criteria:
Exclusion Criteria
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CMV-seronegative Allogeneic Stem Cell Transplant Recipients with CMV seropositive donors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene García Cadenas, MD | Contact | 934893000 | IGarciaCa@santpau.cat | |
| Jose Luis Piñana, MD | Contact | jlpinana@gmail.com |
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Engraftment incidence and time to engraftment
| Day +100 post-SCT |
| Death by any cause and death not related with disease relapse or progression | All-cause mortality week 14 | Week 14 post-SCT |
| Death by any cause non related to relapse | Non-relapse Mortality (NRM) | Week 14 post-SCT |
| Death by any cause non related to relapse | Non-relapse Mortality (NRM) | Week 24 post-SCT |
| 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) |
| 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 |
| 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 |
| Incidence of untreated CMV DNAemia | Incidence of low levels of CMV DNAemia not requiring PET | 180 days post-SCT |
| Adverse events according to the CTCAE, physical examination and regular laboratory tests | To evaluate LMV tolerance and safety | 180 days post-SCT |
| 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 |
| 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 |
| 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 |
| 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 |