CMVPhase 2NCT06453460
CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
A Phase 2 study testing Letermovir, CMV T Cell Immunity Panel (CMV-TCIP) and CMV DNA PCR in people with CMV and Allogeneic Stem Cell Transplantation, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV, Allogeneic Stem Cell Transplantation
- What is being tested?
- Letermovir, CMV T Cell Immunity Panel (CMV-TCIP) and CMV DNA PCR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
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- Be able to comply with medical recommendations or follow-up.
- Has adequate organ functions determined by
- Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).
- Bilirubin ≤1.5 mg/dl except for Gilbert's disease.
- ALT or AST ≤200 IU/ml for adults.
- Conjugated (direct) bilirubin < 2x upper limit of normal.
- Left ventricular ejection fraction ≥40%.
- Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.
Who cannot join
- 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:
- Ganciclovir
- Valganciclovir
- Foscarnet
- Acyclovir (> 3200 mg PO per day or > 25 mg/kg IV per day)
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- Valacyclovir (> 3000 mg/day)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California, 92868
Piyanuch Kongtim, MD, PhD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
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
- Being tested
- Letermovir, CMV T Cell Immunity Panel (CMV-TCIP), CMV DNA PCR
- Keywords
- CMV T Cell Immunity Panel, CMV reactivation, Allogeneic stem cell transplantation, Letermovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
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 PCRDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| AHCT recipients | Experimental | Not described Receives: Drug: Letermovir; Device: CMV T Cell Immunity Panel (CMV-TCIP); Diagnostic Test: CMV DNA PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after transplant
Secondary outcomes (4)
Cumulative incidence of CMV disease at 52 weeks after transplant
Number of patients who develop CMV disease within 52 weeks after receiving a transplant
Measured: 1 year after transplant
Cumulative incidence of CMV related death at 52 weeks
Number of patients who die from complications directly attributable to CMV infection within 52 weeks
Measured: 1 year after transplant
Overall Survival at 1 year after transplant
Number of patients who survive beyond 1 year after transplant
Measured: 1 year after transplant
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
Measured: 1 year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start27 Jun 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMVStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Eurofins Viracor
- Responsible party
- Principal investigator, Piyanuch Kongtim, University of California, Irvine
- Investigators
- Piyanuch Kongtim, MD,PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453460
- Sponsor's protocol ID
- 4005
- Other IDs
- UCI 22-188
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT06453460
- Acronym / sponsor ID
- 4005
- Conditions
- CMV, Allogeneic Stem Cell Transplantation
- Keywords
- CMV T Cell Immunity Panel, CMV reactivation, Allogeneic stem cell transplantation, Letermovir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Eurofins Viracor
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHCT recipients | Experimental | Drug: Letermovir, Device: CMV T Cell Immunity Panel (CMV-TCIP), Diagnostic Test: CMV DNA PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥ 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.
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetermovirSubjects will receive 14 weeks of letermovir prophylaxis at standard recommended dose follow by CMV-TCIP-directed extended prophylaxis. | Drug | AHCT recipients |
| 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. | Device | AHCT recipients |
| CMV DNA PCRPlasma 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. | Diagnostic test | AHCT recipients |
Primary outcome
Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant
Time frame: 1 year after transplant
Number of patients who develop CS-CMVi within 52 weeks after receiving a transplant
4 secondary outcomes
Cumulative incidence of CMV disease at 52 weeks after transplant
Time frame: 1 year after transplant
Cumulative incidence of CMV related death at 52 weeks
Time frame: 1 year after transplant
Overall Survival at 1 year after transplant
Time frame: 1 year after transplant
Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection
Time frame: 1 year after transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Piyanuch Kongtim, MD,PhD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letermovir, CMV T Cell Immunity Panel (CMV-TCIP) and CMV DNA PCR in people with CMV and Allogeneic Stem Cell Transplantation, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant (time frame: 1 year after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 4 Nov 2026.