Health TrialsbyHealthPanel

CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

ConditionsCMVAllogeneic Stem Cell Transplantation
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: AHCT recipientsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant

Number of patients who develop CS-CMVi within 52 weeks after receiving a transplant

Time frame
1 year after transplant

Secondary outcomes

1

Cumulative incidence of CMV disease at 52 weeks after transplant

Number of patients who develop CMV disease within 52 weeks after receiving a transplant

Time frame
1 year after transplant
2

Cumulative incidence of CMV related death at 52 weeks

Number of patients who die from complications directly attributable to CMV infection within 52 weeks

Time frame
1 year after transplant
3

Overall Survival at 1 year after transplant

Number of patients who survive beyond 1 year after transplant

Time frame
1 year after transplant
4

Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection

Positive predictive value of CMV-TCIP assay at 14 weeks after transplant in predicting CS-CMVi protection through 1 year after transplant in patients who had letermovir discontinuation

Time frame
1 year after transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Eurofins Viracor

Collaborator

Source ClinicalTrials.gov
Apply now