Clinical trial NCT06453460: Prospect Eval of Efficacy of CMV-TCIP Direct Letermovir Prophylax After Allogen Hemato Cell Transpla
Official title: Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: CMV
Allogeneic Stem Cell Transplantation
Keywords: CMV T Cell Immunity Panel
CMV reactivation
Allogeneic stem cell transplantation
Letermovir
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Eurofins Viracor
First posted: 2024-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* ≥ 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.
* Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.
* Be within 28 days post-HSCT at the time of enrollment.
* Be able to comply with medical recommendations or follow-up.
* Has adequate organ functions determined by

  1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).
  2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease.
  3. ALT or AST ≤200 IU/ml for adults.
  4. Conjugated (direct) bilirubin \< 2x upper limit of normal.
  5. Left ventricular ejection fraction ≥40%.
  6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.

Exclusion Criteria:

* Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
* Received within 7 days prior to screening or plans to receive during the study any of the following:

  1. Ganciclovir
  2. Valganciclovir
  3. Foscarnet
  4. Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day)
  5. Valacyclovir (\> 3000 mg/day)
  6. Famciclovir (\> 1500 mg/day)
* Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy.
* Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.
* Has an uncontrolled infection on the day of randomization.
* Requires mechanical ventilation or is hemodynamically unstable at the time of randomization.

Primary outcomes:
measure: Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant
timeFrame: 1 year after transplant
Secondary outcomes:
measure: Cumulative incidence of CMV disease at 52 weeks after transplant
timeFrame: 1 year after transplant
measure: Cumulative incidence of CMV related death at 52 weeks
timeFrame: 1 year after transplant
measure: Overall Survival at 1 year after transplant
timeFrame: 1 year after transplant
measure: Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection
timeFrame: 1 year after transplant
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, University of California Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Piyanuch Kongtim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: