NCT06453460 CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
| NCT ID | NCT06453460 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Irvine |
| Condition | CMV |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-06-27 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. * 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
Contact & Investigator
Chao Family Comprehensive Cancer Center University of California, Irvine
✉ ucstudy@uci.edu📞 1-877-827-8839
Piyanuch Kongtim, MD,PhD
PRINCIPAL INVESTIGATOR
Chao Family Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06453460 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CMV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06453460 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06453460 currently recruiting?
Yes, NCT06453460 is actively recruiting participants. Contact the research team at ucstudy@uci.edu for enrollment information.
Where is the NCT06453460 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT06453460 clinical trial?
NCT06453460 is sponsored by University of California, Irvine. The principal investigator is Piyanuch Kongtim, MD,PhD at Chao Family Comprehensive Cancer Center. The trial plans to enroll 50 participants.