CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

NCT ID: NCT06453460

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2029-06-30

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.

Conditions

CMV; Allogeneic Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AHCT recipients

Group Type: EXPERIMENTAL

Letermovir

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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.

Interventions

Letermovir

Subjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis.

Intervention Type: DRUG

CMV T Cell Immunity Panel (CMV-TCIP)

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.

Intervention Type: DEVICE

CMV DNA PCR

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.

Intervention Type: DIAGNOSTIC_TEST

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.
• Must be within Day-10 thru Day+28 days of planned 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
• Requires mechanical ventilation or is hemodynamically unstable

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins Viracor

UNKNOWN

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Piyanuch Kongtim

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Piyanuch Kongtim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-8839

University of California Irvine Medical

Role: CONTACT

Facility Contacts

Piyanuch Kongtim, MD, PhD

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 22-188

Identifier Type: OTHER

Identifier Source: secondary_id

4005

Identifier Type: -

Identifier Source: org_study_id