CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT | NCT06453460

Studies
CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

NCT06453460

Sponsor

University of California, Irvine

Status

Recruiting

Last Update Posted

Jul 9, 2025Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

CMV
Allogeneic Stem Cell Transplantation

Interventions

Letermovir
CMV T Cell Immunity Panel (CMV-TCIP)
CMV DNA PCR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UCI 22-188	Other Identifier	UCI

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 27, 2024Actual

Primary Completion Date

Jun 2028Estimated

Completion Date

Jun 2029Estimated

First Submitted Date

Jun 5, 2024

First Submission Date that Met QC Criteria

Jun 5, 2024

First Posted Date

Jun 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2025

Last Update Posted Date

Jul 9, 2025Actual

Name	Class
Eurofins Viracor	UNKNOWN

Label	Type	Description	Intervention Names
AHCT recipients	Experimental		Drug: Letermovir Device: CMV T Cell Immunity Panel (CMV-TCIP) Diagnostic Test: CMV DNA PCR

Name	Type	Description	Arm Group Labels	Other Names
Letermovir	Drug	Subjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis.	AHCT recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 year after transplant

Secondary Outcomes

Measure	Description	Time Frame
Cumulative incidence of CMV disease at 52 weeks after transplant	Number of patients who develop CMV disease within 52 weeks after receiving a transplant	1 year after transplant
Cumulative incidence of CMV related death at 52 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Chao Family Comprehensive Cancer Center University of California, Irvine	Contact	1-877-827-8839		ucstudy@uci.edu
University of California Irvine Medical	Contact