CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

University of California Irvine (UCI)

Status and phase

Enrolling

Phase 2

Conditions

CMV

Allogeneic Stem Cell Transplantation

Treatments

Diagnostic Test: CMV DNA PCR

Device: CMV T Cell Immunity Panel (CMV-TCIP)

Drug: Letermovir

Study type

Interventional

Funder types

Other

Identifiers

NCT06453460

UCI 22-188 (Other Identifier)

4005

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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