Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT06453460
Eligibility Criteria:
Inclusion 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
1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).
2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease.
3. ALT or AST ≤200 IU/ml for adults.
4. Conjugated (direct) bilirubin \< 2x upper limit of normal.
5. Left ventricular ejection fraction ≥40%.
6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.
Exclusion Criteria:
* 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:
1. Ganciclovir
2. Valganciclovir
3. Foscarnet
4. Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day)
5. Valacyclovir (\> 3000 mg/day)
6. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06453460
Study Brief:
Protocol Section:
NCT06453460