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



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


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


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.


  • 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


accepting new patients
Start Date
Completion Date
University of California, Irvine
Phase 2 research study
Study Type
Expecting 50 study participants
Last Updated