Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell
ConditionCell Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years of age.
Have an ECOG performance status of 0 or 1.
The participant must be scheduled for SOC AXI-CEL.
The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies)
Disqualifiers
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection not responding to treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Female participants who are pregnant or breastfeeding.
Unwilling or unable to follow protocol requirements.
Planned to receive any other anti-CMV therapy such as high dose acyclovir (500 mg/m2/dose intravenously every 8 hours or 800 mg orally 4 times a day) or high dose valacyclovir (2 grams three to four times daily or 2 grams three times daily) for the prophylaxis of CMV reactivation. Acyclovir or valacyclovir at lower doses for the prevention of HSV and VZV are allowed.
Trial design
Design model
Single group
Treatments tested in this trial
Letermovir
DrugGiven by mouth or intravenously
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Open label Single arm: LetermovirExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov