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New treatment option for CMV
Official title CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
ClinicalTrials.gov ID: NCT06453460
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, being studied as a potential treatment for cmv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years of age on the day of signing informed consent.
- Karnofsky performance \>70%
- Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.
- Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral...
- Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.
You likely can't join if
- Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
- Received within 7 days prior to screening or plans to receive during the study any of the following:
- Ganciclovir
- Valganciclovir
- Foscarnet
- Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day)
See the full eligibility criteria
- ≥ 18 years of age on the day of signing informed consent.
- Karnofsky performance \>70%
- Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.
- Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.
- Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.
- Must be within Day-10 thru Day+28 days of planned HSCT at the time of enrollment.
- Be able to comply with medical recommendations or follow-up.
- Has adequate organ functions determined by
- Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).
- Bilirubin ≤1.5 mg/dl except for Gilbert's disease.
- ALT or AST ≤200 IU/ml for adults.
- Conjugated (direct) bilirubin \< 2x upper limit of normal.
- Left ventricular ejection fraction ≥40%.
- Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.
- Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
- Received within 7 days prior to screening or plans to receive during the study any of the following:
- Ganciclovir
- Valganciclovir
- Foscarnet
- Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day)
- Valacyclovir (\> 3000 mg/day)
- Famciclovir (\> 1500 mg/day)
- Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy.
- Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.
- Has an uncontrolled infection
- Requires mechanical ventilation or is hemodynamically unstable
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.