Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
completion around
Principal Investigator
by Piyanuch Kongtim
Headshot of Piyanuch Kongtim
Piyanuch Kongtim

Description

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.

Official Title

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

Keywords

CMV, Allogeneic Stem Cell Transplantation, CMV T Cell Immunity Panel, CMV reactivation, Letermovir, CMV T Cell Immunity Panel (CMV-TCIP), CMV DNA PCR, AHCT recipients

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥ 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.
  • Be within 28 days post-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.

You CAN'T join 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:
    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 on the day of randomization.
  • Requires mechanical ventilation or is hemodynamically unstable at the time of randomization.

Location

  • Chao Family Comprehensive Cancer Center, University of California Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Piyanuch Kongtim
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 57 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06453460
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated