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Letermovir (LMV) prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients with CMV seropositive donors
EU CTIS ID: 2024-516011-24-01
What this study is testing
To determinate the incidence of csCMV infection through week 14 post-SCT.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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.
You likely can't join if
- Active pre-emptive therapy for csCMV-I.
- 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.
- Patients who have received LMV prophylaxis prior to enrollment.
- Glomerular filtration rate (GFR) </=30 mL/min/1.73m^2 (equivalent to creatinine clearance (ClCr) </=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.
See the full eligibility 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.
- Active pre-emptive therapy for csCMV-I.
- 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.
- Patients who have received LMV prophylaxis prior to enrollment.
- Glomerular filtration rate (GFR) </=30 mL/min/1.73m^2 (equivalent to creatinine clearance (ClCr) </=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 LMV
- Patients with previous untreated reactivation.
- Pregnancy or breastfeeding.
- Plans to conceive or father children within the projected duration of the trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.