Actively Recruiting
CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
Led by University of California, Irvine · Updated on 2025-07-09
50
Participants Needed
1
Research Sites
257 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
E
Eurofins Viracor
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of signing informed consent
- Karnofsky performance status greater than 70%
- Documented seropositivity for CMV in either donor or recipient before transplant
- Eligible for allogeneic hematopoietic cell transplantation from specified donor types
- Undetectable CMV DNA in plasma within 5 days before enrollment
- Within Day-10 to Day+28 of planned stem cell transplant at enrollment
- Ability to comply with medical recommendations and follow-up
- Adequate organ function, including creatinine clearance ≥ 50 ml/min, bilirubin ≤ 1.5 mg/dl (except Gilbert's disease), ALT or AST ≤ 200 IU/ml, conjugated bilirubin < 2x upper limit normal, left ventricular ejection fraction ≥ 40%, and DLCO ≥ 50% predicted corrected for hemoglobin
You will not qualify if you...
- History of CMV end-organ disease or clinically significant CMV infection within 6 months before enrollment
- Use or planned use within 7 days prior to screening of ganciclovir, valganciclovir, foscarnet, high-dose acyclovir, valacyclovir, or famciclovir
- Use or planned use within 30 days prior to screening of cidofovir, CMV hyper-immune globulin, or investigational CMV antiviral/biologic therapy
- Known or suspected hypersensitivity to letermovir or its components
- Presence of uncontrolled infection
- Requirement for mechanical ventilation or hemodynamic instability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
U
University of California Irvine Medical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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