Evaluating CMV Prophylaxis After Stem Cell Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial investigates the effectiveness of the CMV T Cell Immunity Panel (CMV-TCIP) assay in determining the duration of CMV prophylaxis using Letermovir for patients who are CMV-seropositive and have undergone allogeneic stem cell transplantation. The study aims to optimize CMV management by tailoring prophylactic treatment based on individual immune responses. Participants will be monitored for CMV reactivation and overall health outcomes following their transplant.

Why it matters

Who can join: the full rules

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

  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.

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:

  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
* Requires mechanical ventilation or is hemodynamically unstable

Where it's running

• Chao Family Comprehensive Cancer Center, University of California Irvine
  Orange, California, United States Recruiting

Study contacts

• Principal investigator: Piyanuch Kongtim, MD,PhD — Chao Family Comprehensive Cancer Center
• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
• Email: ucstudy@uci.edu
• Phone: 1-877-827-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.