Prospect Eval of Efficacy of CMV-TCIP Direct Letermovir Prophylax After Allogen Hemato Cell Transpla

Phase 2

Recruiting

• Conditions: CMV; Allogeneic Stem Cell Transplantation
• Interventions: Drug: Letermovir; Device: CMV T Cell Immunity Panel (CMV-TCIP); Diagnostic Test: CMV DNA PCR

• Registration Number: NCT06453460
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-11
• Study Start: 2024-06-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• Primary Completion: 2028-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AHCT recipients	CMV T Cell Immunity Panel (CMV-TCIP)	-
AHCT recipients	CMV DNA PCR	-
AHCT recipients	Letermovir	-

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant	1 year after transplant	Number of patients who develop CS-CMVi within 52 weeks after receiving a transplant

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of CMV disease at 52 weeks after transplant	1 year after transplant	Number of patients who develop CMV disease within 52 weeks after receiving a transplant
Cumulative incidence of CMV related death at 52 weeks	1 year after transplant	Number of patients who die from complications directly attributable to CMV infection within 52 weeks
Overall Survival at 1 year after transplant	1 year after transplant	Number of patients who survive beyond 1 year after transplant
Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection	1 year after transplant	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

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center, University of California Irvine; 🇺🇸 Orange, California, United States