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Virus Therapy

Letermovir + CMV-TCIP for Cytomegalovirus After Stem Cell Transplant

Phase 2
Recruiting
Led By Piyanuch Kongtim, MD,PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
≥ 18 years of age on the day of signing informed consent
Must not have
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), 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 on the day of randomization, Requires mechanical ventilation or is hemodynamically unstable at the time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new test called CMV T Cell Immunity Panel (CMV-TCIP) to see if it can help determine how long patients need to take medication to prevent CMV

Who is the study for?
This trial is for adults over 18 who've had a stem cell transplant from a CMV-positive donor or are themselves CMV-positive. They must have good organ function, no recent severe infections, and not be taking certain antiviral drugs. It's not for those with recent CMV disease or allergies to Letermovir.
What is being tested?
The study tests if monitoring the immune response to CMV (using the CMV-TCIP assay) can guide how long patients should take Letermovir as prevention against CMV after an allogeneic stem cell transplant.
What are the potential side effects?
Possible side effects of Letermovir include headache, nausea, vomiting, diarrhea, coughing, swelling in limbs, fatigue and may affect liver enzymes leading to abnormal blood test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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I am eligible for a stem cell transplant from a donor who is a match or partially matches me.
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I had a stem cell transplant less than 28 days ago.
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I or my donor have tested positive for CMV before my stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant
Secondary study objectives
Cumulative incidence of CMV disease at 52 weeks after transplant
Cumulative incidence of CMV related death at 52 weeks
Overall Survival at 1 year after transplant
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AHCT recipientsExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
2019
Completed Phase 3
~1530

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,932,998 Total Patients Enrolled
Eurofins ViracorUNKNOWN
Piyanuch Kongtim, MD,PhDPrincipal InvestigatorChao Family Comprehensive Cancer Center
~33 spots leftby Jun 2028
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