RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy

Quick Facts

Study Start:2024-12-12

Study Completion:2027-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06575374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years of age. 2. Have an ECOG performance status of 0 or 1. 3. The participant must be scheduled for SOC AXI-CEL. 4. The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies) 5. Creatinine clearance \> 10 mL/min 6. Child Pugh class A or B if liver disease is present. 7. 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. 8. 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.	1. 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. 2. Female participants who are pregnant or breastfeeding. 3. Unwilling or unable to follow protocol requirements. 4. 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. 5. Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug. 6. Evidence for CMV infection defined as any positive CMV DNA qPCR test within 1 week prior to starting letermovir. 7. Child Pugh class C liver disease.

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years of age.
2. Have an ECOG performance status of 0 or 1.
3. The participant must be scheduled for SOC AXI-CEL.
4. The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies)
5. Creatinine clearance \> 10 mL/min
6. Child Pugh class A or B if liver disease is present.
7. 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.
8. 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.

1. 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.
2. Female participants who are pregnant or breastfeeding.
3. Unwilling or unable to follow protocol requirements.
4. 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.
5. Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
6. Evidence for CMV infection defined as any positive CMV DNA qPCR test within 1 week prior to starting letermovir.
7. Child Pugh class C liver disease.

Contacts and Locations

Study Contact

George Chen, MD

CONTACT

(713) 792-3630

glchen1@mdanderson.org

Principal Investigator

George Chen, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

George Chen, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12

Study Completion Date2027-08-01

Study Record Updates

Study Start Date2024-12-12

Study Completion Date2027-08-01

Terms related to this study

Additional Relevant MeSH Terms

Cell Therapy