CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
Recruiting now · Phase 2
Conditions studied: CMV, Allogeneic Stem Cell Transplantation
In brief
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.
Key facts
- Study ID
- NCT06453460
- Run by
- University of California, Irvine
- People needed
- 50
- Starts
- 2024-06-27
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 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.
You may not qualify 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)
- 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
Where it is running
- Chao Family Comprehensive Cancer Center, University of California Irvine — Orange, California, United States (enrolling)
Full record on ClinicalTrials.gov
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