RecruitingPhase 2NCT06453460

CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Sponsor

University of California, Irvine

Enrollment

50 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

CMV

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

Min Age: 18 Years

Inclusion Criteria14

≥ 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.

Exclusion Criteria12

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

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLetermovir

Subjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis.

DEVICECMV T Cell Immunity Panel (CMV-TCIP)

Viracor CMV-TCIP assay to measure how a person's immune system responds to CMV. Viracor CMV-TCIP will be measured monthly, starting at week 14, until positive, then at week 30 and 52.

DIAGNOSTIC_TESTCMV DNA PCR

Plasma level of CMV DNA PCR will be measured at enrollment and at least weekly through week 30, then at least every 2 weeks through week 52 of transplant if no GVHD or CMV reactivation.