CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
Qualifiers
≥ 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.
Disqualifiers
Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
Ganciclovir
Valganciclovir
Foscarnet
Trial design
Treatments tested in this trial
- Letermovir
- CMV T Cell Immunity Panel (CMV-TCIP)
- CMV DNA PCR
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, Irvine
Lead sponsor
Eurofins Viracor
Collaborator
Source ClinicalTrials.gov