The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis

Официальное название

The Efficacy and Safety of Tofacitinib in Patients With Glucocorticoid Resistant ICIs-related Myocarditis: a Single-arm, Prospective, Phase 2 Trial

Обзор

The efficacy and safety of Tofacitinib in patients with glucocorticoid resistant ICIs-related myocarditis: a single-arm, prospective, phase 2 trial

Вмешательства

• Препарат Tofacitinib 5 MG BID
  Tofacitinib 5 MG BID

Первичные конечные точки

• All-cause mortality within three months [Срок оценки: The first three months after tofacitinib administration]

Вторичные конечные точки (4)

• All-cause mortality within six months [Срок оценки: The firs six months after tofacitinib administration]
• Progression-free survival [Срок оценки: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months]
• Overall survival [Срок оценки: From date of enrollment until the date of death from any cause, assessed up to 24 months"]
• Safety and tolerability based on incidence of treatment-emergent adverse events [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Age ≥ 18 years old
• Patients treated with ICI immunotherapy (monotherapy or combination), including anti-PD1, anti-PDL1, anti-CTLA4; and including any type of cancer (even those in which ICI is not currently approved by regulatory)
• Definite, probable or possible ICI-induced myocarditis according to the diagnostic criteria of the most recent expert consensus recommendations (e.g27, to be updated with any new recommendations to be published)
• corticosteroid-resistant ICI-myocarditis: Corticosteroid-resistant ICI-myocarditis is defined by the absence of decrease in troponin levels or the appearance/persistence of severity criteria despite receiving prednisone dose ≥0.5 mg/kg/day for ≥2 days.
• Signature of informed consent before any trial procedure from the patient or legal representative or the close relative
• Patients covered by social security regimen (excepting AME)
• Withhold of ICI

Критерии исключения

• Untreated and/or uncontrolled bacterial, fungal, or viral infection Pregnancy, breast-feeding or planning to become pregnant during the study period
• For women of childbearing age, lack of effective contraception throughout the duration of participation in the study
• Being treated with tofacitinib within 3 months prior to inclusion Known hypersensitivity to abatacept or belatacept
• Being treated with anti-thymoglobulin, or alemtuzumab within 6 weeks of the first scheduled dose of abatacept
• Patient participating to another interventional study (RIPH 1 only) People under legal protection measure (tutorship, curatorship or safeguard measures)

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06393972 · ZSLCYJ202353

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗