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Recruiting NCT06453460

CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

Phase II Interventional CMV Allogeneic Stem Cell Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Letermovir, CMV T Cell Immunity Panel (CMV-TCIP), CMV DNA PCR.
Who it may be relevant to
Registry conditions: CMV, Allogeneic Stem Cell Transplantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant [Time frame: 1 year after transplant]
Secondary outcome measures (4)
  • Cumulative incidence of CMV disease at 52 weeks after transplant [Time frame: 1 year after transplant]
  • Cumulative incidence of CMV related death at 52 weeks [Time frame: 1 year after transplant]
  • Overall Survival at 1 year after transplant [Time frame: 1 year after transplant]
  • Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection [Time frame: 1 year after transplant]

Eligibility criteria

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
  • 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 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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Chao Family Comprehensive Cancer Center, University of California Irvine — Orange

Identifiers

NCT: NCT06453460 · 4005 · UCI 22-188

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗