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NCT06575374 | NOT YET RECRUITING | Cell Therapy

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

M.D. Anderson Cancer Center

Brief Summary:

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

Condition or disease

Cell Therapy

Intervention/treatment

Letermovir

Phase

NA

Detailed Description:

Primary Objective: Estimate the probabilities at days d = +28 and +98 following CAR T cell infusion, among patients alive at the day of evaluation, of CMV reactivation in CMV seropositive patients receiving letermovir for CMV prophylaxis after standard of care (SOC) axicabtagene ciloleucel (AXI-CEL) therapy, using the cutoff CMV DNA qPCR \> c for c = 400 and 1000 IU/mL to define CMV reactivation, for a total of four (d, c) combinations. Secondary Objectives: Estimate overall survival probabilities at days+28, +98, and +364 following CAR T cell infusion of CMV seropositive patients receiving letermovir for CMV prophylaxis after SOC AXI-CEL therapy. Describe the tolerability of letermovir during the period of CMV prophylaxis after SOC AXI-CEL therapy in CMV seropositive patients at high risk for CMV reactivation.

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy
Actual Study Start Date : 2024-12-31
Estimated Primary Completion Date : 2026-08-01
Estimated Study Completion Date : 2027-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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.
Exclusion Criteria
  • 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.
Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy

Location Details

NCT06575374

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How to Participate

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Locations

Not yet recruiting

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030