CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

NCT06453460 | Recruiting Phase 2 FDA Drug FDA Device

• 2 other identifiers: 4005UCI 22-188
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CMV; Allogeneic Stem Cell Transplantation

Keywords

CMV T Cell Immunity Panel; CMV reactivation; Allogeneic stem cell transplantation; Letermovir

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant

  Number of patients who develop CS-CMVi within 52 weeks after receiving a transplant

  1 year after transplant

Secondary Outcomes (4)

• Cumulative incidence of CMV disease at 52 weeks after transplant

  1 year after transplant

• Cumulative incidence of CMV related death at 52 weeks

  1 year after transplant

• Overall Survival at 1 year after transplant

  1 year after transplant

• Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection

  1 year after transplant

Study Arms (1)

AHCT recipients

EXPERIMENTAL

Drug: Letermovir; Device: CMV T Cell Immunity Panel (CMV-TCIP); Diagnostic Test: CMV DNA PCR

Interventions

Letermovir DRUG

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

AHCT recipients

CMV T Cell Immunity Panel (CMV-TCIP) DEVICE

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.

AHCT recipients

CMV DNA PCR DIAGNOSTIC_TEST

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.

AHCT recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Irvine: lead
• Eurofins Viracor: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Interventions

letermovir

Study Officials

• Piyanuch Kongtim, MD,PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)