CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT
Recruiting
Phase 2Interventional Study
CMVAllogeneic Stem Cell Transplantation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
University of California, Irvine · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 unrel…
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
Contacts
Chao Family Comprehensive Cancer Center University of California, Irvine
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