Actively Recruiting
Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
Led by University of California, Irvine · Updated on 2025-07-09
50
Participants Needed
1
Research Sites
52 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
Researchers are evaluating a new approach using the CMV T Cell Immunity Panel (CMV-TCIP) assay to guide how long primary cytomegalovirus (CMV) prevention treatment lasts in adults who have received allogeneic stem cell transplants and are CMV-positive or received a transplant from a CMV-positive donor. This phase 2 trial aims to better understand how to manage CMV prophylaxis after transplantation to reduce risks associated with CMV infection. Participants will receive 14 weeks of the antiviral drug letermovir at the recommended dose. After this period, the CMV-TCIP assay will be used monthly starting at week 14 to measure immune response to CMV until a positive result occurs; then testing will continue at weeks 30 and 52. Additionally, plasma CMV DNA levels will be monitored weekly through week 30, then every two weeks until week 52 if no graft-versus-host disease or CMV reactivation occurs. During the study, participants will be regularly tested using the CMV-TCIP assay and CMV DNA PCR to track their immune response and viral activity. The main outcome measured is the rate of significant CMV infection within one year after transplant. Secondary outcomes include rates of CMV disease, CMV-related death, overall survival, and the predictive value of the CMV-TCIP assay. Participants will be followed for one year after transplantation to assess these outcomes.
CONDITIONS
Brief 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 informed consent
- Karnofsky performance score greater than 70%
- Documented CMV seropositivity in donor or recipient before transplantation
- Eligible for allogeneic hematopoietic cell transplantation from matched related, matched unrelated, mismatched unrelated, or haploidentical donor
- Undetectable CMV DNA in plasma within 5 days before enrollment
- Enrollment between 10 days before to 28 days after planned stem cell transplant
- 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 less than twice upper normal limit, 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 during study of ganciclovir, valganciclovir, foscarnet, high-dose acyclovir, valacyclovir, or famciclovir within 7 days prior to screening
- Use or planned use during study of cidofovir, CMV hyper-immune globulin, or investigational CMV antiviral agents within 30 days prior to screening
- Known or suspected hypersensitivity to letermovir or its ingredients
- Uncontrolled infection
- Requirement for mechanical ventilation or hemodynamic instability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive 14 weeks of letermovir prophylaxis at the standard recommended dose followed by CMV-TCIP-directed extended prophylaxis.
Weekly visits through week 30, then visits at least every 2 weeks through week 52
Duration - Up to 52 weeks
Participants have monthly CMV-TCIP immune response tests starting at week 14 until positive, then at weeks 30 and 52.
Monthly visits starting at week 14, additional visits at weeks 30 and 52
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
U
University of California Irvine Medical
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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