CMVNCT06211543
Letermovir (LMV) Prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients With CMV Seropositive Donors: an Exploratory Study From Spanish GETH/TC Centers
An observational study of CMV, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CMV-seronegative Allogeneic Stem Cell Transplant Recipients with CMV seropositive donors
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
No sites are listed yet.
Jose Luis Piñana, MD contact
About this study
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).
Read the detailed 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).
- Conditions
- CMV
- Keywords
- CMV, Allogeneic Stem Cell Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV DNAemia requiring preemptive treatment or CMV disease
To determinate the incidence of csCMV infection through week 14 post-SCT.
Measured: Week 14 post-SCT
Secondary outcomes (14)
Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +40 post-SCT.
Engraftment incidence and time to engraftment
Measured: Day +40 post-SCT
Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +100 post-SCT.
Engraftment incidence and time to engraftment
Measured: Day +100 post-SCT
Death by any cause and death not related with disease relapse or progression
All-cause mortality week 14
Measured: Week 14 post-SCT
Death by any cause non related to relapse
Non-relapse Mortality (NRM)
Measured: Week 14 post-SCT
Death by any cause non related to relapse
Non-relapse Mortality (NRM)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 180 days post-SCT
Incidence of untreated CMV DNAemia
Incidence of low levels of CMV DNAemia not requiring PET
Measured: 180 days post-SCT
Adverse events according to the CTCAE, physical examination and regular laboratory tests
To evaluate LMV tolerance and safety
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 180 days post-SCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211543
- Sponsor's protocol ID
- GETH-LMV
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06211543
- Acronym / sponsor ID
- GETH-LMV
- Conditions
- CMV
- Keywords
- CMV, Allogeneic Stem Cell Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celularUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CMV-seronegative Allogeneic Stem Cell Transplant Recipients with CMV seropositive donors
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CMV DNAemia requiring preemptive treatment or CMV disease
Time frame: Week 14 post-SCT
To determinate the incidence of csCMV infection through week 14 post-SCT.
14 secondary outcomes
Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +40 post-SCT.
Time frame: Day +40 post-SCT
Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +100 post-SCT.
Time frame: Day +100 post-SCT
Death by any cause and death not related with disease relapse or progression
Time frame: Week 14 post-SCT
Death by any cause non related to relapse
Time frame: Week 14 post-SCT
Death by any cause non related to relapse
Time frame: 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)
Time frame: Up to 8 weeks of study-drug administration period (day +100 post-transplant)
Duration of any CMV-antiviral treatment by day 180 post-SCT
Time frame: day 180 post-SCT
Incidence of blips, clinical and analytic characteristics.
Time frame: 180 days post-SCT
Incidence of untreated CMV DNAemia
Time frame: 180 days post-SCT
Adverse events according to the CTCAE, physical examination and regular laboratory tests
Time frame: 180 days post-SCT
Incidence of aGVHD within 120 days after HCT and its onset and severity
Time frame: 120 days post-SCT
Incidence of relapse within 180 days after HCT and its onset and severity
Time frame: 180 days post-SCT
Incidence of CMV DNAemia requiring PET within 100-180 days after HCT
Time frame: From day 100 to day 180 after HCT
Incidence of non-CMV infections within 180 days after HCT and its onset and severity
Time frame: 180 days post-SCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Piñana, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of CMV, run by Grupo Espanol de trasplantes hematopoyeticos y terapia celular.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene García Cadenas, MD (934893000, IGarciaCa@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV DNAemia requiring preemptive treatment or CMV disease (time frame: Week 14 post-SCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.