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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Letermovir
  Given by mouth or intravenously

Первичные конечные точки

• Safety and Adverse Events (AEs) [Срок оценки: Through study completion; an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06575374 · 2023-0828 · NCI-2024-07402

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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