Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell

NCT06575374 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2023-0828NCI-2024-07402
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.

Conditions

Cell Therapy

Outcome Measures

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

  Through study completion; an average of 1 year

Study Arms (1)

Open label Single arm: Letermovir

EXPERIMENTAL

Participants will be identified/recruited/screened from the Lymphoma and Stem Cell Transplantation and Cellular Therapy services at MD Anderson Cancer Center.

Drug: Letermovir

Interventions

Letermovir DRUG

Given by mouth or intravenously

Open label Single arm: Letermovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Creatinine clearance \> 10 mL/min
• Child Pugh class A or B if liver disease is present.
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.
• Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

You may not qualify if:

• 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.
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
• Evidence for CMV infection defined as any positive CMV DNA qPCR test within 1 week prior to starting letermovir.
• Child Pugh class C liver disease.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

letermovir

Study Officials

• George Chen, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Chen, MD

CONTACT

(713) 792-3630; glchen1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)