NCT06453460PHASE2Recruiting
CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
University of California, Irvine
Start Date
6/27/2024
Completion Date
6/1/2029
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
Letermovir
DEVICE
CMV T Cell Immunity Panel (CMV-TCIP)
DIAGNOSTIC_TEST
CMV DNA PCR
Conditions
CMVAllogeneic Stem Cell Transplantation
Locations
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California 92868
United States