CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06453460
Phase
PHASE2
Status
Recruiting
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Conditions

  • Allogeneic Stem Cell Transplantation
  • CMV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Letermovir — DRUG
    Subjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis.
  • CMV T Cell Immunity Panel (CMV-TCIP) — DEVICE
    Viracor CMV-TCIP assay to measure how a person's immune system responds to CMV. Viracor CMV-TCIP will be measured monthly, starting at week 14, until positive, then at week 30 and 52.
  • CMV DNA PCR — DIAGNOSTIC_TEST
    Plasma level of CMV DNA PCR will be measured at enrollment and at least weekly through week 30, then at least every 2 weeks through week 52 of transplant if no GVHD or CMV reactivation.

Study Details

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.

Key Dates

Start date
Jun 27, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AHCT recipients

Primary Outcome Measure

Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant [ Time Frame: 1 year after transplant ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California IrvineOrangeCalifornia92868
Piyanuch Kongtim, MD, PhD
[email protected]
877-827-8839

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By research site
Chao Family Comprehensive Cancer Center, University of California Irvine· Orange, CA

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